Boston Scientific Corp - FDA 510(k) Cleared Devices
432
Total
411
Cleared
0
Denied
432 devices
Cleared
Jul 14, 2003
VAXCEL WITH PASV PORT, MODEL 45-213
General Hospital
14d
Cleared
Jun 27, 2003
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
Gastroenterology & Urology
42d
Cleared
May 23, 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
Gastroenterology & Urology
57d
Cleared
Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG...
Gastroenterology & Urology
30d
Cleared
Mar 25, 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
Gastroenterology & Urology
25d
Cleared
Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
Gastroenterology & Urology
67d
Cleared
Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
Gastroenterology & Urology
26d
Cleared
Jan 28, 2003
VAXCEL WITH PASV PORT
General Hospital
19d
Cleared
Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
Cardiovascular
25d
Cleared
Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310,...
Ear, Nose, Throat
42d
Cleared
Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
General & Plastic Surgery
141d
Cleared
Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
Gastroenterology & Urology
161d
Cleared
Oct 17, 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
General & Plastic Surgery
15d
Cleared
Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
Gastroenterology & Urology
74d
Cleared
Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
Gastroenterology & Urology
27d
Cleared
Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
Cardiovascular
28d
Cleared
Aug 22, 2002
CONTOUR SE MICROSPHERES
Neurology
28d
Cleared
Aug 08, 2002
URETERAL STENT
Gastroenterology & Urology
267d
Cleared
Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON...
Gastroenterology & Urology
200d
Cleared
Jul 11, 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
General & Plastic Surgery
232d
Cleared
Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
Gastroenterology & Urology
190d
Cleared
Jun 20, 2002
EQUALIZER BALLOON CATHETER
Cardiovascular
27d
Cleared
May 16, 2002
CONSTELLATION CATHETERS, MODEL 8031M
Cardiovascular
28d
Cleared
Apr 19, 2002
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
Cardiovascular
2d
Cleared
Apr 16, 2002
COBRA COOLED SURGICAL PROBE, MODEL 1596X
General & Plastic Surgery
15d
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