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
101-125 of 179
Cleared Mar 13, 1998
COAXIAL DILATOR SET
K974640 · DRE
Cardiovascular · 88d
Cleared Feb 10, 1998
40 CC GRANDE
K974247 · DSP
Cardiovascular · 90d
Cleared Dec 16, 1997
T-REX BIOPSY FORCEPS
K973818 · DWZ
Cardiovascular · 70d
Cleared Dec 11, 1997
COURIER ST BALLOON DILATATION CATHETER
K972744 · LIT
Cardiovascular · 141d
Cleared Nov 19, 1997
BLUE MAX - 20 BALLOON DILATATION CATHETER
K972357 · LIT
Cardiovascular · 147d
Cleared Nov 19, 1997
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · KRA
Cardiovascular · 56d
Cleared Sep 02, 1997
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
K972113 · DSP
Cardiovascular · 89d
Cleared Aug 29, 1997
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K970296 · MCW
Cardiovascular · 214d
Cleared Aug 05, 1997
40 CC SUMO
K971673 · DSP
Cardiovascular · 90d
Cleared Jul 31, 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
K970207 · DQO
Cardiovascular · 191d
Cleared Jul 24, 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
K971607 · DQO
Cardiovascular · 84d
Cleared Jul 23, 1997
INTRODUCER SHEATH AND DILATOR
K971165 · LDF
Cardiovascular · 114d
Cleared Jul 01, 1997
TRANSEND EX PLATINUM GUIDEWIRE
K971254 · DQX
Cardiovascular · 89d
Cleared May 01, 1997
CHANNEL BALLOON CATHETER
K970379 · LIT
Cardiovascular · 87d
Cleared Jan 28, 1997
TRANSEND GUIDEWIRE
K964611 · DQX
Cardiovascular · 71d
Cleared Jan 06, 1997
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM
K964284 · DTK
Cardiovascular · 70d
Cleared Dec 12, 1996
INTRAVASCULAR INFUSION DEVICE
K963988 · KRA
Cardiovascular · 69d
Cleared Nov 04, 1996
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930...
K963187 · DSP
Cardiovascular · 82d
Cleared Oct 22, 1996
ELECTRODE RECORDING CATHETER
K954651 · DRF
Cardiovascular · 378d
Cleared Apr 09, 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K960501 · LIT
Cardiovascular · 67d
Cleared Mar 11, 1996
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
K953750 · DRF
Cardiovascular · 214d
Cleared Feb 09, 1996
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER...
K955396 · DTK
Cardiovascular · 77d
Cleared Jan 11, 1996
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
K954431 · DSP
Cardiovascular · 108d
Cleared Dec 20, 1995
COURIER BALLOON DILATATION CATHETER
K953569 · LIT
Cardiovascular · 142d
Cleared Nov 14, 1995
XXL BALLON DILATATION CATHETER
K952063 · LIT
Cardiovascular · 196d

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