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
126-150 of 179
Cleared Oct 18, 1995
SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
K953602 · LIT
Cardiovascular · 77d
Cleared Sep 21, 1995
PRECEDER GUIDEWIRE
K953023 · DQX
Cardiovascular · 84d
Cleared Sep 12, 1995
EVOLUTION MICROCATHETER
K953114 · DQO
Cardiovascular · 71d
Cleared Aug 18, 1995
MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM
K952828 · DYB
Cardiovascular · 59d
Cleared Aug 11, 1995
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
K952221 · DSP
Cardiovascular · 91d
Cleared Jun 22, 1995
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM
K951508 · DTK
Cardiovascular · 80d
Cleared Jun 21, 1995
EVOLUTION(TM) MICROCATHETER
K945666 · KRA
Cardiovascular · 216d
Cleared Jun 15, 1995
STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY
K912035 · DTK
Cardiovascular · 1498d
Cleared Jun 05, 1995
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
K945379 · DQX
Cardiovascular · 215d
Cleared May 04, 1995
LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
K951744 · DRF
Cardiovascular · 35d
Cleared Apr 28, 1995
PRECEDER GUIDEWIRE
K950352 · DQX
Cardiovascular · 88d
Cleared Apr 06, 1995
BSC/CA MODEL 940 IAB
K940298 · DSP
Cardiovascular · 440d
Cleared Mar 23, 1995
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
K943919 · DSP
Cardiovascular · 223d
Cleared Dec 08, 1994
GUIDE WIRE
K942453 · DQX
Cardiovascular · 199d
Cleared Oct 14, 1994
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232 · DSP
Cardiovascular · 289d
Cleared Jun 17, 1994
PLATINUM PLUS GUIDEWIRE
K935997 · DQX
Cardiovascular · 184d
Cleared Feb 10, 1994
GUIDING CATHETER
K930476 · DQY
Cardiovascular · 377d
Cleared Jan 26, 1994
MAGIC TORQUE GUIDEWIRE
K933334 · DQX
Cardiovascular · 202d
Cleared Dec 09, 1993
NEW BLUE MAX BALLOON DILATATION CATHETER
K934191 · LIT
Cardiovascular · 105d
Cleared Nov 10, 1993
ULTRA THIN BALLOON DILATATION CATHETER
K924320 · LIT
Cardiovascular · 440d
Cleared Nov 04, 1993
ULTRA THIN BALLOON DILATATION CATHETER
K923611 · LIT
Cardiovascular · 471d
Cleared Sep 03, 1993
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
K924163 · DRF
Cardiovascular · 380d
Cleared Aug 30, 1993
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
K926000 · DSP
Cardiovascular · 276d
Cleared Dec 08, 1992
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573 · MAV
Cardiovascular · 190d
Cleared Dec 03, 1992
BLUE MAX II BALLOON DDILATATION CATHETER
K921254 · LIT
Cardiovascular · 262d

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