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
179 devices
76-100 of 179
Cleared Aug 01, 2003
IQ HYDROPHILIC GUIDE WIRE
K032183 · DQX
Cardiovascular · 15d
Cleared Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
K023681 · DQO
Cardiovascular · 25d
Cleared Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
K022621 · DQO
Cardiovascular · 28d
Cleared Jun 20, 2002
EQUALIZER BALLOON CATHETER
K021721 · DQY
Cardiovascular · 27d
Cleared May 16, 2002
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · MTD
Cardiovascular · 28d
Cleared Apr 19, 2002
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
K021213 · MAL
Cardiovascular · 2d
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 Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906 · DQX
Cardiovascular · 55d
Cleared Jun 21, 2001
6F MACH 1, MODEL 34356-XXX
K010874 · DQY
Cardiovascular · 90d
Cleared Mar 01, 2001
ASTRONOMER+WITH SLD
K003362 · DQK
Cardiovascular · 125d
Cleared Feb 14, 2001
CONSTELLATION CATHETER, MODEL 8031
K003782 · MTD
Cardiovascular · 69d
Cleared Sep 26, 2000
CONSTELLATION CATHETERS
K000277 · MTD
Cardiovascular · 239d
Cleared Aug 31, 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · LIT
Cardiovascular · 143d
Cleared Jun 08, 2000
TALON BALLOON DILATION CATHETER
K000798 · LIT
Cardiovascular · 87d
Cleared May 18, 2000
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K992320 · LIT
Cardiovascular · 311d
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 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 12, 1999
CONSTELLATION CATHETERS, MODEL 8039
K992777 · MTD
Cardiovascular · 86d
Cleared Oct 07, 1999
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · DYB
Cardiovascular · 90d
Cleared Mar 11, 1999
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
K983171 · MTD
Cardiovascular · 182d
Cleared Feb 23, 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · MCW
Cardiovascular · 232d

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