FDA 510(k) Applications for Medical Device Product Code "LOX"
(Catheters, Transluminal Coronary Angioplasty, Percutaneous)

FDA 510(k) Number Applicant Device Name Decision Date
K110617 Abbott Vascular MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER 06/02/2011
K123279 Abbott Vascular MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN 01/30/2013
K113464 Abbott Vascular NC TREK OTW CORONARY DILATATION CATHETER 03/06/2012
K180040 Abbott Vascular NC TREKÖ RX Coronary Dilatation Catheter; NC TREKÖ OTW Coronary Dilatation Catheter; TREKÖ RX Coronary Dilatation Catheter; TREKÖ OTW Coronary Dilatation Catheter; MINI TREKÖ RX Coronary Dilatation Catheter; MINI TREKÖ OTW Coronary Dilatation Catheter; MI 08/24/2018
K121222 Abbott Vascular TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER 06/22/2012
K103110 ABBOTT VASCULAR-CARDIAC THERAPIES MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER 01/10/2011
K110134 ABBOTT VASCULAR-CARDIAC THERAPIES NC TREK RX CORONARY DILATATION CATHETER 02/11/2011
K103153 ABBOTT VASCULAR-CARDIAC THERAPIES VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER 12/30/2010
K861847 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE 06/16/1986
K843944 ADVANCED CARDIOVASCULAR SYSTEMS, INC. PTCA BALLOON CATHETERS & ACCESSORIES 02/14/1985
K162625 B. BRAUN INTERVENTIONAL SYSTEMS INC. SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters 06/12/2017
K160985 BIOTRONIK, INC Pantera Pro 10/07/2016
K163660 BIOTRONIK, INC. Pantera LEO 01/26/2017
K130391 BOSTON SCIENTIFIC CORP. EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT 07/10/2013
K121196 BOSTON SCIENTIFIC CORP. EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) 08/31/2012
K121667 BOSTON SCIENTIFIC CORP. NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) 08/13/2012
K163174 Boston Scientific Corporation Emerge PTCA Dilatation Catheter 12/14/2016
K113220 Boston Scientific Corporation EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) 03/22/2012
K163200 BOSTON SCIENTIFIC CORPORATION Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete 12/14/2016
K141236 Boston Scientific Corporation NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) 08/07/2014
K160823 BOSTON SCIENTIFIC CORPORATION NC Quantum Apex PTCA Dilatation Catheter 06/23/2016
K134031 Boston Scientific Corporation THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER 07/21/2014
K133852 BROSMED MEDICAL APOLLO BALLOON DILATATION CATHETER 09/19/2014
K141025 BROSMED MEDICAL ARTIMES BALLOON DILATATION CATHETER 09/12/2014
K153742 BrosMed Medical Co., Ltd. Apollo Balloon Dilatation Catheter 08/08/2016
K110133 CREGANNA-TACTX MEDICAL EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER 06/10/2011
K820410 HEMOTEC, INC. HEMOTEC HEPCON/SYSTEM FOUR & FOUR P 04/09/1982
K123264 INTUIT MEDICAL, LLC DK-PTCA BALLOON CATHETER 01/16/2013
K172264 Kaneka Corporation OTW Takeru PTCA Balloon Dilatation Catheter 03/19/2018
K170941 Kaneka Corporation RX NC Takeru PTCA Balloon Dilatation Catheter 07/07/2017
K163372 KANEKA CORPORATION RX Takeru Balloon Dilatation Catheter 04/07/2017
K182699 Kossel Medtech (Suzhou) Co., Ltd. Selethru PTCA Balloon Dilatation Catheter 11/26/2018
K123473 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD HOPER PTCA BALLOON CATHETER 08/13/2013
K162434 MEDINOL LTD. NC Gallant PTCA Catheter 01/19/2017
K173581 Medinol, Ltd. Gallant PTCA Dilatation Catheter 01/25/2018
K143480 MEDTRONIC INC. Euphora Rapid Exchange Balloon Dilatation Catheter 04/02/2015
K141090 MEDTRONIC INC. NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER 08/15/2014
K103095 MEDTRONIC IRELAND SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON 10/22/2010
K131169 MERIL LIFE SCIENCES PRIVATE LIMITED MOZEC - RX PTCA BALLOON DILATATION CATHETER 12/24/2013
K160961 MERIL LIFE SCIENCES PRIVATE LIMITED Mozec NC-Rx PTCA Baloon Dilatation Catheter 07/30/2016
K181023 Meril Life Sciences Private Limited Mozec û Rx PTCA Balloon Dilatation Catheter, Mozec NC û Rx PTCA Balloon Dilatation Catheter 05/17/2018
K141933 NATEC MEDICAL LTD FILAO NC RX PTCA DILATATION CATHETER 06/28/2015
K112735 NATEC MEDICAL LTD TAMARIN BLUE PTCA RX DILATATION CATHETER 11/02/2012
K163114 OrbusNeich Medical Inc. Sapphire II PRO 01/05/2017
K173680 OrbusNeich Medical Trading Inc. Sapphire II PRO 03/01/2018
K180921 OrbusNeich Medical Trading Inc. Sapphire II PRO Balloon Dilatation Catheter 06/28/2018
K162209 OrbusNeich Medical, Inc Sapphire NC Plus 10/06/2016
K103657 ORBUSNEICH MEDICAL, INC. SAPPHIRE 08/09/2011
K103808 ORBUSNEICH MEDICAL, INC. SAPPHIRE NC 09/01/2011
K131450 OSTIAL CORPORATION FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 08/06/2013
K152485 OSTIAL CORPORATION FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm 02/16/2016
K122178 OSTIAL CORPORATION FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 10/11/2012
K113775 OSTIAL CORPORATION FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM 06/29/2012
K111284 OSTIAL CORPORATION FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM 08/17/2011
K896108 SCIMED LIFE SYSTEMS, INC. THE PILOT SCIMED TORQUE DEVICE 01/09/1990
K143160 SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD FOXTROT NC PTCA Balloon Catheter 03/05/2015
K133633 TRIREME MEDICAL INC CHOCOLATE PTCA BOLLOON CATHETER 06/02/2014
K111544 TRIREME MEDICAL INC GLIDER PTCA BALLOON CATHETER 03/02/2012
K121681 TRIREME MEDICAL, INC. GLIDER PTCA BALLOON CATHETER 06/26/2012
K150292 TRIREME MEDICAL, LLC Chocolate PTCA Balloon Catheter 04/09/2015
K153682 TriReme Medical, LLC Chocolate XD PTCA Balloon Catheter 06/23/2016


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