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
126-150 of 432
Cleared Jun 08, 2005
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
K051179 · NFA
Cardiovascular · 30d
Cleared Jun 03, 2005
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
K050599 · DQY
Cardiovascular · 86d
Cleared May 25, 2005
ULTRA-SOFT SV BALLOON DILATATION CATHETER
K050389 · DQY
Cardiovascular · 99d
Cleared May 20, 2005
ATLANTIS PV
K050684 · DQO
Radiology · 64d
Cleared Apr 15, 2005
MATRIX STRETCH RESISTANT (SR) COILS
K050700 · HCG
Neurology · 28d
Cleared Mar 30, 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
K050577 · DQO
Cardiovascular · 23d
Cleared Mar 14, 2005
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
K050361 · GEI
General & Plastic Surgery · 28d
Cleared Mar 11, 2005
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
K050232 · PID
Gastroenterology & Urology · 38d
Cleared Mar 04, 2005
SPYGLASS DIRECT VISULATION PROBE
K050403 · ODF
Gastroenterology & Urology · 15d
Cleared Feb 08, 2005
EASY CORE BIOPSY SYSTEM II
K050120 · FCG
Gastroenterology & Urology · 21d
Cleared Nov 10, 2004
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
K041818 · ITX
Radiology · 127d
Cleared Nov 09, 2004
ENTERYX INJECTION CATHETER
K042882 · FBK
Gastroenterology & Urology · 21d
Cleared Oct 19, 2004
GDC-10 360 DEGREE COIL SR
K042539 · HCG
Neurology · 29d
Cleared Oct 15, 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568 · DQY
Cardiovascular · 24d
Cleared Sep 30, 2004
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
K042065 · MQR
Gastroenterology & Urology · 59d
Cleared Aug 06, 2004
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
K041827 · GCJ
General & Plastic Surgery · 30d
Cleared Jul 22, 2004
PTFE FELTS AND PLEDGETS
K041716 · DXZ
Cardiovascular · 28d
Cleared Jul 07, 2004
EXTRACTOR RX RETRIEVAL BALLOON
K041606 · FGE
Gastroenterology & Urology · 22d
Cleared Jul 01, 2004
PERIPHERAL CUTTING BALLOON
K040155 · PNO
Cardiovascular · 160d
Cleared May 18, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K040736 · MSD
Gastroenterology & Urology · 57d
Cleared May 06, 2004
EASY CORE BIOPSY SYSTEM
K040893 · FCG
Gastroenterology & Urology · 30d
Cleared Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867 · DQX
Cardiovascular · 28d
Cleared Apr 29, 2004
ATLANTIS SR, MODEL C4020
K040776 · DQO
Cardiovascular · 34d
Cleared Apr 28, 2004
CONCERTO BIPOLAR NEEDLE ELECTRODE
K040785 · GEI
General & Plastic Surgery · 30d
Cleared Apr 22, 2004
RESOLUTION HEMOSTASIS CLIPPING DEVICE
K040148 · MCH
General & Plastic Surgery · 90d

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