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
162 devices
51-75 of 162
Cleared Jun 27, 2003
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
K031538 · KNT
Gastroenterology & Urology · 42d
Cleared May 23, 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
K030956 · FED
Gastroenterology & Urology · 57d
Cleared Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG...
K030855 · KNT
Gastroenterology & Urology · 30d
Cleared Mar 25, 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
K030645 · FGE
Gastroenterology & Urology · 25d
Cleared Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107 · FGE
Gastroenterology & Urology · 67d
Cleared Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
K030503 · FAD
Gastroenterology & Urology · 26d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · FGE
Gastroenterology & Urology · 161d
Cleared Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
K022135 · KOD
Gastroenterology & Urology · 74d
Cleared Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648 · KNT
Gastroenterology & Urology · 27d
Cleared Aug 08, 2002
URETERAL STENT
K013784 · FAD
Gastroenterology & Urology · 267d
Cleared Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON...
K020120 · KNT
Gastroenterology & Urology · 200d
Cleared Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297 · KNT
Gastroenterology & Urology · 190d
Cleared Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS...
K020824 · FHN
Gastroenterology & Urology · 29d
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 Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · KOD
Gastroenterology & Urology · 18d
Cleared Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · ODD
Gastroenterology & Urology · 27d
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 Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
K010002 · FAD
Gastroenterology & Urology · 20d
Cleared Oct 12, 2000
NIR BILLIARY STENT SYSTEM
K002133 · FGE
Gastroenterology & Urology · 90d

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