Medical Device Manufacturer · US , Plymouth , MN

Boston Scientific Scimed, Inc. - FDA 510(k) Cleared Devices

35 submissions · 26 cleared · Since 1994
35
Total
26
Cleared
0
Denied

Boston Scientific Scimed, Inc. has 26 FDA 510(k) cleared medical devices. Based in Plymouth, US.

Historical record: 26 cleared submissions from 1994 to 2004. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Boston Scientific Scimed, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Boston Scientific Scimed, Inc.

35 devices
1-12 of 35
Cleared Jul 23, 2004
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
K041727 · OBJ
Cardiovascular · 28d
Cleared May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · DQX
Cardiovascular · 84d
Cleared Jan 06, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K024048 · FGE
Gastroenterology & Urology · 28d
Cleared Aug 08, 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
K021735 · DQY
Cardiovascular · 72d
Cleared Jul 09, 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
K021901 · JCT
General & Plastic Surgery · 29d
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY...
K012822 · FGE
Gastroenterology & Urology · 62d
Cleared Aug 17, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216 · FGE
Gastroenterology & Urology · 32d
Cleared Sep 06, 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
K000743 · DQO
Cardiovascular · 183d
Cleared Jun 05, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K000001 · JCT
General & Plastic Surgery · 154d
Cleared Apr 21, 2000
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
K000956 · DQO
Cardiovascular · 28d
Cleared Dec 30, 1999
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K993232 · FGE
Gastroenterology & Urology · 94d
Cleared Aug 23, 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
K992123 · DQO
Cardiovascular · 61d
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