FDA 510(k) Applications for Medical Device Product Code "DRB"
(Stylet, Catheter)

FDA 510(k) Number Applicant Device Name Decision Date
K770404 ABBOTT LABORATORIES OBTURATOR 03/16/1977
K000366 ACCUFIX RESEARCH INSTITUTE FIXATION STYLETS, MODELS 335-287 AND 335-288 04/14/2000
K905674 CARDIAC PACEMAKERS, INC. LEAD STYLET 01/30/1991
K802076 CARDIAC PACEMAKERS, INC. STIFF STYLETS 09/26/1980
K170298 Cook Incorporated Liberator Beacon Tip Locking Stylet 10/18/2017
K993376 ENDOCARDIAL SOLUTIONS, INC. ENSTYLET MODELS EC0010, EC0020 01/05/2000
K002534 EUPALAMUS, LLC. EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 10/18/2000
K992863 GUIDANT CORP. LEAD STYLET,MODELS 6505,6506,6507,6508 11/12/1999
K053019 GUIDANT CORPORATION ACUITY STEERABLE STYLET ACCESSORY 03/03/2006
K052965 GUIDANT CORPORATION EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. 02/13/2006
K913543 INTL. MEDICAL DEVICES LTD. THORACIC CATHETER STYLET 10/04/1991
K010906 MEDTRONIC VASCULAR MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 04/05/2001
K000955 MEDTRONIC VASCULAR PLACER MODEL 6232 STEERABLE STYLET 06/16/2000
K003535 MEDTRONIC VASCULAR STYLET KIT, MODELS 6254,6282,6293 02/08/2001
K882097 QUINTON, INC. TUNNELING STYLET 07/28/1988
K990713 SPECTRANETICS CORP. SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER 10/22/1999
K043401 SPECTRANETICS CORP. SPECTRANETICS LLD CS, MODEL 518-039 03/16/2005
K142116 SPECTRANETICS, INC. LLD EZ 08/12/2014
K090163 ST. JUDE MEDICAL STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 04/01/2009
K080924 ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 04/30/2008
K072864 ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM 03/13/2008
K040001 SYNOVIS SURGICAL INNOVATIONS STEERABLE STYLET 03/09/2004
K914001 TARGET THERAPEUTICS TARGET THERAPEUTICS RADIOPAQUE STYLET 11/22/1991
K992664 TFX MEDICAL GROUP TFX MEDICAL STYLET CATHETER 04/13/2000
K901281 VAL-MARK MEDICAL, INC. THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER 08/28/1991


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