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
432 devices
101-125 of 432
Cleared Dec 05, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
K063313 · NTE
Cardiovascular · 33d
Cleared Dec 04, 2006
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS...
K062750 · MUM
Gastroenterology & Urology · 81d
Cleared Nov 30, 2006
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS,...
K063312 · DQO
Radiology · 28d
Cleared Oct 20, 2006
OCCLUSION BALLOON
K062202 · DQY
Cardiovascular · 80d
Cleared Sep 21, 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · KNQ
Gastroenterology & Urology · 87d
Cleared Sep 15, 2006
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K061877 · MQR
Gastroenterology & Urology · 74d
Cleared Sep 01, 2006
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · FGE
Gastroenterology & Urology · 122d
Cleared Aug 11, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
K061332 · NFA
Cardiovascular · 91d
Cleared Apr 19, 2006
SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020
K060947 · ITX
Radiology · 13d
Cleared Apr 10, 2006
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190,...
K051984 · NFA
Cardiovascular · 262d
Cleared Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
K060175 · DQO
Cardiovascular · 60d
Cleared Mar 13, 2006
CONCERTO BIPOLAR NEEDLE ELECTRODE
K060419 · GEI
General & Plastic Surgery · 24d
Cleared Jan 06, 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED...
K052964 · DSY
Cardiovascular · 77d
Cleared Jan 04, 2006
RIO ASPIRATION CATHETER
K051880 · QEZ
Cardiovascular · 177d
Cleared Dec 16, 2005
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
K053116 · DQY
Cardiovascular · 39d
Cleared Dec 16, 2005
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
K053118 · DQY
Cardiovascular · 39d
Cleared Nov 30, 2005
SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
K053128 · GEI
General & Plastic Surgery · 22d
Cleared Nov 07, 2005
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
K052280 · NFA
Cardiovascular · 77d
Cleared Oct 27, 2005
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
K052783 · DQX
Cardiovascular · 24d
Cleared Sep 12, 2005
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
K052302 · MAL
Cardiovascular · 19d
Cleared Sep 02, 2005
IMAGER II ANGIOGRAPHIC CATHETER
K050863 · DQO
Cardiovascular · 150d
Cleared Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
K052194 · ODF
Gastroenterology & Urology · 13d
Cleared Jul 14, 2005
ILAB ULTRASOUND IMAGING SYSTEM
K051679 · OBJ
Cardiovascular · 21d
Cleared Jun 16, 2005
EASY CORE DETACHABLE BIOPSY SYSTEM
K051361 · KNW
Gastroenterology & Urology · 22d
Cleared Jun 16, 2005
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · FED
Gastroenterology & Urology · 9d

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