FDA 510(k) Applications Submitted by BOSTON SCIENTIFIC SCIMED, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K030617 02/26/2003 PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE BOSTON SCIENTIFIC SCIMED, INC.
K021735 05/28/2002 BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER BOSTON SCIENTIFIC SCIMED, INC.
K012216 07/16/2001 NIROYAL BILIARY PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC SCIMED, INC.
K961262 04/02/1996 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC.
K961296 04/04/1996 WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC.
K961507 04/19/1996 WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC.
K964119 10/15/1996 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC.
K964121 10/15/1996 WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC.
K000743 03/07/2000 BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 BOSTON SCIENTIFIC SCIMED, INC.
K982077 06/12/1998 SELECTOR DIAGNOSTIC CATHETER BOSTON SCIENTIFIC SCIMED, INC.
K980113 01/13/1998 WALLSTENT ENTERAL ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC.
K954290 09/14/1995 WALLSTENT ENTERAL ENDOPROTHESIS BOSTON SCIENTIFIC SCIMED, INC.
K961499 04/18/1996 LAGUNA SOFTIP DIAGNOSTIC CATHETERS BOSTON SCIENTIFIC SCIMED, INC.
K981413 04/20/1998 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS BOSTON SCIENTIFIC SCIMED, INC.
K961999 05/22/1996 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS BOSTON SCIENTIFIC SCIMED, INC.
K000956 03/24/2000 MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS BOSTON SCIENTIFIC SCIMED, INC.
K992123 06/23/1999 SCIMED IMPULSE ANGIOGRAPHIC CATHETERS BOSTON SCIENTIFIC SCIMED, INC.
K982184 06/22/1998 WALLSTENT ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC.
K041727 06/25/2004 MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 BOSTON SCIENTIFIC SCIMED, INC.
K000001 01/03/2000 WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM BOSTON SCIENTIFIC SCIMED, INC.
K980453 02/05/1998 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS BOSTON SCIENTIFIC SCIMED, INC.
K972512 07/07/1997 SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL BOSTON SCIENTIFIC SCIMED, INC.
K980163 01/16/1998 WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING BOSTON SCIENTIFIC SCIMED, INC.
K982005 06/08/1998 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC.
K993232 09/27/1999 WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM BOSTON SCIENTIFIC SCIMED, INC.
K021901 06/10/2002 WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM BOSTON SCIENTIFIC SCIMED, INC.
K012822 08/23/2001 MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX BOSTON SCIENTIFIC SCIMED, INC.
K024048 12/09/2002 MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC SCIMED, INC.


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