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
26-50 of 179
Cleared Aug 13, 2012
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
K121667 · LOX
Cardiovascular · 68d
Cleared May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495 · DQO
Cardiovascular · 94d
Cleared Apr 03, 2012
ENCORE 26 ADVANTAGE KIT
K120694 · MAV
Cardiovascular · 27d
Cleared Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · DQO
Cardiovascular · 6d
Cleared Aug 12, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K112103 · KRD
Cardiovascular · 21d
Cleared Jun 30, 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
K111498 · DQX
Cardiovascular · 30d
Cleared Jun 02, 2011
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
K111252 · DQY
Cardiovascular · 30d
Cleared Apr 08, 2011
ACUITY WHISPER VIEW GUIDE WIRES
K110479 · DQX
Cardiovascular · 49d
Cleared Mar 03, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K110295 · KRD
Cardiovascular · 30d
Cleared Feb 11, 2011
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM...
K102714 · KRD
Cardiovascular · 144d
Cleared Apr 12, 2010
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
K100892 · KRA
Cardiovascular · 12d
Cleared Dec 23, 2009
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL...
K093636 · LIT
Cardiovascular · 29d
Cleared Dec 23, 2009
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL...
K093720 · LIT
Cardiovascular · 21d
Cleared Jul 02, 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554 · DQX
Cardiovascular · 122d
Cleared Feb 03, 2009
BLAZER DX-20 DIAGNOSTIC CATHETER
K081576 · DRF
Cardiovascular · 243d
Cleared Aug 08, 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · DQX
Cardiovascular · 120d
Cleared Jul 14, 2008
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
K080982 · LIT
Cardiovascular · 98d
Cleared Mar 07, 2008
CONVOY ADVANCED DELIVERY SHEATH
K072719 · DYB
Cardiovascular · 164d
Cleared Jul 13, 2007
BLUE MAX BALLOON DILATATION CATHETER
K071309 · LIT
Cardiovascular · 65d
Cleared Jun 13, 2007
POLARCATH PERIPHERAL DILATATION SYSTEM
K071042 · LIT
Cardiovascular · 62d
Cleared Dec 05, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
K063313 · NTE
Cardiovascular · 33d
Cleared Oct 20, 2006
OCCLUSION BALLOON
K062202 · DQY
Cardiovascular · 80d
Cleared Aug 11, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
K061332 · NFA
Cardiovascular · 91d
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

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