FDA 510(k) Applications Submitted by COOK INCORPORATED

FDA 510(k) Number Submission Date Device Name Applicant
K110163 01/19/2011 APPROACH PRO ST WIRE GUIDE COOK INCORPORATED
K123235 10/16/2012 EQUAFLOW MULTIVALVE INFUSION CATHETER COOK INCORPORATED
K172217 07/24/2017 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath Cook Incorporated
K180028 01/03/2018 Cook 810 Set, Desilets-Hoffman Introducer Set Cook Incorporated
K180756 03/22/2018 Safety Wire Guide Introducer COOK Incorporated
K181431 06/01/2018 Laser Ureteral Catheter Cook Incorporated
K171662 06/05/2017 Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ure Cook Incorporated
K172588 08/29/2017 Balloon Catheter and Balloon Ureteral Dilator Set Cook Incorporated
K160593 03/01/2016 Indy OTW Vascular Retriever COOK INCORPORATED
K150970 04/13/2015 Coda LP Balloon Catheter COOK INCORPORATED
K181144 05/01/2018 Angled Tip Ureteral Catheter Cook Incorporated
K170020 01/03/2017 Peel-Away Introducer Set Cook Incorporated
K171915 06/26/2017 Nathanson Transcystic Bile Duct Stone Exploration Pack Cook Incorporated
K172325 08/01/2017 Rhapsody H-30 Holmium Laser System Cook Incorporated
K173009 09/27/2017 NCompass Nitinol Stone Extractors Cook Incorporated
K173414 11/01/2017 Advance Biliary Balloon Catheter Cook Incorporated
K163197 11/15/2016 Cook Holmium Laser Fiber COOK INCORPORATED
K173685 12/01/2017 Peel-Away Introducer Set Cook Incorporated
K173687 12/01/2017 Strange Bile Duct Stone Exploration Set Cook Incorporated
K173355 10/25/2017 Gastric Sizing Balloon Catheter Cook Incorporated
K124030 12/28/2012 COOK HOLMIUM LASER FIBER COOK INCORPORATED
K172980 09/27/2017 Micropuncture Pedal Access Set Cook Incorporated
K170193 01/23/2017 Advance 14LP Low Profile PTA Balloon Dilatation Catheter COOK INCORPORATED
K170616 03/01/2017 van Andel Dilatation Catheter Cook Incorporated
K160884 03/31/2016 CXI Support Catheter COOK INCORPORATED
K171275 05/01/2017 Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design Cook Incorporated
K133788 12/12/2013 COOK HOLMIUM LASER FIBER COOK INCORPORATED
K160219 01/29/2016 Hilal Embolization MicroCoils Cook Incorporated
K171820 06/19/2017 Transjugular Liver Access Sets Cook Incorporated
K171853 06/21/2017 Liver Access and Biopsy Sets Cook Incorporated
K151676 06/22/2015 Retracta Detachable Embolization Coil COOK INCORPORATED
K153778 12/31/2015 Nester Embolization Coils, Tornado Embolization Coils COOK INCORPORATED
K133114 09/30/2013 MICROPUNCTURE INTRODUCER SET COOK INCORPORATED
K173289 10/16/2017 Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter Cook Incorporated
K140085 01/13/2014 UNIVERSA PERCULTANEOUS DRAINAGE CATHETER COOK INCORPORATED
K170008 01/03/2017 Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set COOK INCORPORATED
K170323 02/01/2017 Entuit Start Initial Placement Gastrostomy Set Cook Incorporated
K160509 02/24/2016 Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube COOK INCORPORATED
K160567 02/29/2016 Barone Jejunostomy Catheter Set COOK INCORPORATED
K170898 03/27/2017 Wittich Nitinol Stone Basket Cook Incorporated
K161002 04/11/2016 Aprima Smartesis Centesis Pump COOK INCORPORATED
K171603 06/01/2017 Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set Cook Incorporated
K152524 09/03/2015 Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set COOK INCORPORATED
K173035 09/28/2017 Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets Cook Incorporated
K170603 03/01/2017 Tao Brush I.U.M.C. Endometrial Sampler Cook Incorporated
K171604 06/01/2017 R÷sch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip Cook Incorporated
K181712 06/28/2018 San Antonio Stopcock Cook Incorporated
K151051 04/20/2015 Universa Soft Ureteral Stents and Stent Sets COOK INCORPORATED
K161236 05/02/2016 Universa Firm Ureteral Stents and Stent Sets COOK INCORPORATED
K171445 05/16/2017 Amplatz Support Wire Guide with Apex Curve Cook Incorporated
K181351 05/22/2018 Double Flexible Tipped Wire Guides Cook Incorporated
K171609 06/01/2017 Check-Flo Performer Introducer Micropuncture Radial Artery Access Set Cook Incorporated
K171764 06/14/2017 Fixed Core Wire Guides Cook Incorporated
K171897 06/26/2017 Approach CTO Microwire Guide Cook Incorporated
K171912 06/26/2017 Double Flexible Tip Wire Guides Cook Incorporated
K171948 06/29/2017 Roadrunner Extra Support Wire Guide Cook Incorporated
K161822 07/01/2016 Torcon NB Advantage Catheters Cook Incorporated
K171997 07/03/2017 Mandril Wire Guide Cook Incorporated
K171999 07/03/2017 Performer Introducer Cook Incorporated
K123712 12/04/2012 RETRACTA DETACHABLE EMBOLIZATION COIL COOK INCORPORATED
K161218 04/29/2016 Gianturco-Roehm BirdÆs Nest Vena Cava Filter COOK INCORPORATED
K171264 05/01/2017 Royal Flush Catheter Cook Incorporated
K161801 06/30/2016 CrossCath Support Catheter Cook Incorporated
K162448 09/01/2016 White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter Cook Incorporated
K172635 09/01/2017 High-Flo Silver Polyethylene Catheter Cook Incorporated
K171994 07/03/2017 Silicone Peripherally Inserted Central Venous Catheter Set/Tray Cook Incorporated
K173155 09/29/2017 Pakter Curved Needle Set Cook Incorporated
K163031 10/31/2016 Bunegin-Albin Air Aspiration Set COOK INCORPORATED
K150802 03/26/2015 Heavy Double Flexible Tipped Wire Guide COOK INCORPORATED
K160887 03/31/2016 Cook Intraosseous Infusion Needles COOK INCORPORATED
K160217 01/29/2016 uVue HSG/SHG Catheter COOK INCORPORATED
K160891 03/31/2016 Ultrathane Endoureterotomy Stent Set Cook Incorporated
K162109 07/29/2016 Kwart Retro-Inject Ureteral Stent COOK INCORPORATED
K081337 05/13/2008 APPROACH CTO WIRE GUIDE COOK INCORPORATED
K172017 07/03/2017 Black Silicone Filiform Double Pigtail Stent Set Cook Incorporated
K160200 01/28/2016 Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set COOK INCORPORATED
K160542 02/26/2016 5.0 Fr Arndt Endobronchial Blocker Set COOK INCORPORATED
K171917 06/27/2017 Frova Intubating Introducer Cook Incorporated
K162729 09/29/2016 Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip COOK INCORPORATED
K173654 11/28/2017 Ureteral Dilator Sets, Ureteral Dilators Cook Incorporated
K153761 12/30/2015 Emergency Transtracheal Airway Catheter COOK INCORPORATED
K170010 01/03/2017 Salle Intraoperative Pyeloplasty Stent Set COOK INCORPORATED
K171601 06/01/2017 Ultraxx Nephrostomy Balloon Catheter Cook Incorporated
K181713 06/28/2018 Ultraxx Nephrostomy Balloon Catheter Set Cook Incorporated
K162104 07/29/2016 C-Flex Ureteral Stent Set COOK INCORPORATED
K073528 12/17/2007 VENA CAVA FILTER COOK INCORPORATED
K111263 05/04/2011 CXI TRIFORCE COOK INCORPORATED
K170622 03/01/2017 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component Cook Incorporated
K180552 03/01/2018 Modified Novy Cornual Cannulation Set Cook Incorporated
K150748 03/23/2015 Flexipet Denuding Pipette, Flexipet Manipulation Pipette COOK INCORPORATED
K151018 04/16/2015 Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette COOK INCORPORATED
K172051 07/06/2017 GuardiaÖ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter Cook Incorporated
K172321 08/01/2017 Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters Cook Incorporated
K173103 09/29/2017 Pivet and Soft-Pass Embryo Transfer Catheter Sets Cook Incorporated
K173686 12/01/2017 Guardia Access Embryo Transfer Catheter Sets and Sydney IVF« Transfer Catheter Cook Incorporated
K163318 11/23/2016 Soules Intrauterine Insemination Catheter Cook Incorporated
K150931 04/06/2015 MReye Embolization Coils Cook Incorporated
K150964 04/10/2015 MReye Flipper Detachable Embolization Coil and Delivery System Cook Incorporated
K180034 01/04/2018 Weinmann Tracheostomy Exchange Set Cook Incorporated
K171602 06/01/2017 Williams Cystoscopic Injection Needle Cook Incorporated
K172527 08/21/2017 Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe Cook Incorporated
K171988 07/03/2017 Performer Guiding Sheath Cook Incorporated
K173068 09/29/2017 Performer Introducer COOK Incorporated
K171600 06/01/2017 Renal Access Cobra Catheter, Kumpe Access Catheter Cook Incorporated
K172278 07/28/2017 Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent Cook Incorporated
K173105 09/29/2017 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter Cook Incorporated
K173657 11/29/2017 Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter Cook Incorporated
K170931 03/29/2017 CXI TriForce Peripheral Crossing Set Cook Incorporated
K152044 07/23/2015 Flexor Radial Hydrophilic Introducer Access Set COOK INCORPORATED
K142829 09/30/2014 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Co Cook Incorporated
K153430 11/25/2015 Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select COOK INCORPORATED
K132885 09/16/2013 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET COOK INCORPORATED
K160223 01/29/2016 VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter COOK INCORPORATED
K170298 01/31/2017 Liberator Beacon Tip Locking Stylet Cook Incorporated
K150733 03/20/2015 Vital-Port Vascular Access System Power Injectable Port COOK INCORPORATED
K141322 05/20/2014 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER COOK INCORPORATED
K161496 06/01/2016 Turbo-Flo PICC Sets COOK INCORPORATED
K161504 06/01/2016 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray COOK INCORPORATED
K142819 09/29/2014 Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set COOK INCORPORATED
K120468 02/16/2012 NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR COOK INCORPORATED
K100974 04/08/2010 SPECTRUM TURBO-JECT PICC SET COOK INCORPORATED
K081768 06/20/2008 COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES COOK INCORPORATED
K060224 01/30/2006 MODIFICATION TO MIRA-FLEX 18 MICROCATHETER COOK INCORPORATED
K163353 11/30/2016 Needle's Eye Snare Retrieval Set - 54cm Cook Incorporated
K140169 01/23/2014 VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM COOK INCORPORATED
K171272 05/01/2017 Cook-Swartz Doppler Flow Probe Cook Incorporated
K171810 06/19/2017 Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter Cook Incorporated


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