Medical Device Manufacturer · US , San Jose , CA

Boston Scientific Corp - FDA 510(k) Cleared Devices

432 submissions · 411 cleared · Since 1988
432
Total
411
Cleared
0
Denied
432 devices
201-225 of 432
Cleared Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS...
K020824 · FHN
Gastroenterology & Urology · 29d
Cleared Apr 05, 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
K020765 · KTI
Ear, Nose, Throat · 28d
Cleared Mar 19, 2002
KAYAK HYDROPHILIC GUIDE WIRES
K014195 · DOX
Toxicology · 88d
Cleared Feb 11, 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · DQX
Cardiovascular · 14d
Cleared Dec 21, 2001
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · DQY
Cardiovascular · 186d
Cleared Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · FGE
Gastroenterology & Urology · 162d
Cleared Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752 · FGE
Gastroenterology & Urology · 91d
Cleared Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820,...
K012864 · FCG
Gastroenterology & Urology · 58d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153 · KNS
Gastroenterology & Urology · 29d
Cleared Oct 12, 2001
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM,...
K012883 · ESW
Gastroenterology & Urology · 45d
Cleared Aug 24, 2001
VAXCEL DIALYSIS CATHETER
K012365 · MSD
Gastroenterology & Urology · 29d
Cleared Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906 · DQX
Cardiovascular · 55d
Cleared Aug 01, 2001
CENTRAL VENOUS CATHETER
K003839 · LJS
General Hospital · 232d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · KOD
Gastroenterology & Urology · 18d
Cleared Jun 21, 2001
6F MACH 1, MODEL 34356-XXX
K010874 · DQY
Cardiovascular · 90d
Cleared Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · ODD
Gastroenterology & Urology · 27d
Cleared Apr 13, 2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
K010956 · GEI
General & Plastic Surgery · 14d
Cleared Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · ODC
Gastroenterology & Urology · 26d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929 · FGE
Gastroenterology & Urology · 92d
Cleared Mar 01, 2001
ASTRONOMER+WITH SLD
K003362 · DQK
Cardiovascular · 125d
Cleared Feb 14, 2001
CONSTELLATION CATHETER, MODEL 8031
K003782 · MTD
Cardiovascular · 69d
Cleared Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
K010002 · FAD
Gastroenterology & Urology · 20d
Cleared Dec 20, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K003100 · JCT
General & Plastic Surgery · 78d
Cleared Oct 12, 2000
NIR BILLIARY STENT SYSTEM
K002133 · FGE
Gastroenterology & Urology · 90d
Cleared Oct 05, 2000
RAPID EXCHANGE TAPERTOME
K002802 · KNS
Gastroenterology & Urology · 27d

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