Boston Scientific Scimed, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456, PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE, MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
35
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Boston Scientific Scimed, Inc. Cardiovascular ✕
15 devices
Cleared
Jul 23, 2004
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
Cardiovascular
28d
Cleared
May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
Cardiovascular
84d
Cleared
Aug 08, 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
Cardiovascular
72d
Cleared
Sep 06, 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
Cardiovascular
183d
Cleared
Apr 21, 2000
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
Cardiovascular
28d
Cleared
Aug 23, 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
Cardiovascular
61d
Cleared
Aug 11, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
Cardiovascular
187d
Cleared
Aug 11, 1998
SELECTOR DIAGNOSTIC CATHETER
Cardiovascular
60d
Cleared
May 13, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
Cardiovascular
23d
Cleared
Feb 12, 1998
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL
Cardiovascular
220d
Cleared
Nov 19, 1996
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
Cardiovascular
181d
Cleared
Oct 17, 1996
LAGUNA SOFTIP DIAGNOSTIC CATHETERS
Cardiovascular
182d