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
226-250 of 432
Cleared Sep 26, 2000
CONSTELLATION CATHETERS
K000277 · MTD
Cardiovascular · 239d
Cleared Aug 31, 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · LIT
Cardiovascular · 143d
Cleared Aug 30, 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
K001338 · FGE
Gastroenterology & Urology · 125d
Cleared Jul 19, 2000
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
K002084 · FFK
Gastroenterology & Urology · 9d
Cleared Jun 08, 2000
TALON BALLOON DILATION CATHETER
K000798 · LIT
Cardiovascular · 87d
Cleared May 19, 2000
WALLSTENT BILIARY ENDOPROSTHESIS
K000308 · FGE
Gastroenterology & Urology · 108d
Cleared May 18, 2000
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K992320 · LIT
Cardiovascular · 311d
Cleared May 12, 2000
WALLSTENT ENTERNAL PROSTHESIS
K000281 · MQR
Gastroenterology & Urology · 102d
Cleared Apr 13, 2000
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON...
K000570 · LIT
Cardiovascular · 51d
Cleared Apr 10, 2000
TRANSLUMINAL BALLOON DILATATION CATHETER
K993305 · LIT
Cardiovascular · 189d
Cleared Apr 07, 2000
RENEGADE HI-FLO MICROCATHETER
K000177 · KRA
Cardiovascular · 78d
Cleared Mar 23, 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
K993303 · FGE
Gastroenterology & Urology · 171d
Cleared Mar 07, 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K000397 · FHN
Gastroenterology & Urology · 29d
Cleared Feb 28, 2000
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · DWZ
Cardiovascular · 20d
Cleared Jan 04, 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · DYB
Cardiovascular · 18d
Cleared Nov 18, 1999
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K992510 · JCT
General & Plastic Surgery · 114d
Cleared Nov 12, 1999
CONSTELLATION CATHETERS, MODEL 8039
K992777 · MTD
Cardiovascular · 86d
Cleared Oct 07, 1999
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · DYB
Cardiovascular · 90d
Cleared Jul 12, 1999
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · MSD
Gastroenterology & Urology · 375d
Cleared Jun 22, 1999
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
K991056 · MQR
Gastroenterology & Urology · 84d
Cleared Jun 11, 1999
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · MND
Gastroenterology & Urology · 87d
Cleared Mar 11, 1999
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
K983171 · MTD
Cardiovascular · 182d
Cleared Mar 05, 1999
BONE ANCHOR SYSTEM III (BAS III)
K990295 · MBI
Orthopedic · 35d
Cleared Feb 23, 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · MCW
Cardiovascular · 232d
Cleared Nov 09, 1998
BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE...
K982840 · IYO
Radiology · 89d

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