FDA 510(k) Applications Submitted by GUIDANT CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K023627 10/28/2002 ESSEX ENDOSCOPE, MODEL SXD-1000 GUIDANT CORP.
K014250 12/26/2001 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 GUIDANT CORP.
K031678 05/30/2003 HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP.
K010684 03/08/2001 RX HERCULINK PLUS BILIARY STENT SYSTEM GUIDANT CORP.
K000793 03/13/2000 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER GUIDANT CORP.
K061865 07/03/2006 FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 GUIDANT CORP.
K031398 05/05/2003 IS-1 HEMOSTASIS VALVE, MODEL 6799 GUIDANT CORP.
K020161 01/17/2002 AGILTRAC .018 PERIPHERAL DILATATION CATHETER GUIDANT CORP.
K011039 04/05/2001 OMNILINK .018 BILIARY STENT SYSTEM GUIDANT CORP.
K011506 05/16/2001 OMNILINK .035 BILIARY STENT SYSTEM GUIDANT CORP.
K980294 01/27/1998 ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP.
K023300 10/03/2002 HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J GUIDANT CORP.
K022880 08/30/2002 GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 GUIDANT CORP.
K020340 02/01/2002 MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP.
K983033 08/31/1998 ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDANT CORP.
K013092 09/17/2001 HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP.
K021228 04/18/2002 HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE GUIDANT CORP.
K013833 11/19/2001 HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 GUIDANT CORP.
K021285 04/18/2002 HI-TORQUE EXTRA S'PORT GUIDEWIRE GUIDANT CORP.
K021282 04/18/2002 LV-1 HEMOSTASIS VALVE, MODEL #6789 GUIDANT CORP.
K021283 04/18/2002 GUIDANT BALLOON CATHETER, SEVERAL MODELS GUIDANT CORP.
K021284 04/18/2002 EASYTRAK GUIDING CATHETER GUIDANT CORP.
K021455 05/06/2002 RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, GUIDANT CORP.
K061453 05/25/2006 HI-TORQUE WHISPER VIEW GUIDE WIRE GUIDANT CORP.
K033393 10/23/2003 ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM GUIDANT CORP.
K000101 01/13/2000 RX VIATRAC 14 PERIPHERAL DILATATION CATHETER GUIDANT CORP.
K991032 03/29/1999 GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 GUIDANT CORP.
K030019 01/03/2003 MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE GUIDANT CORP.
K042218 08/05/2004 ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM GUIDANT CORP.
K982083 06/15/1998 ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP.
K000598 02/23/2000 5F GUIDING CATHETER GUIDANT CORP.
K990639 02/26/1999 ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING. GUIDANT CORP.
K991152 04/06/1999 HI-TORQUE BALANCE TREK GUIDE WIRE GUIDANT CORP.
K981381 04/16/1998 ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1 GUIDANT CORP.
K001222 04/17/2000 OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 GUIDANT CORP.
K001224 04/17/2000 RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 GUIDANT CORP.
K002206 07/21/2000 HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO GUIDANT CORP.
K973494 09/15/1997 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG GUIDANT CORP.
K983346 09/23/1998 STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF GUIDANT CORP.
K984394 12/08/1998 ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING GUIDANT CORP.
K974773 12/22/1997 HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC GUIDANT CORP.
K021824 06/04/2002 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 GUIDANT CORP.
K010831 03/20/2001 AVIATOR PERIPHERAL DILATATION CATHETER GUIDANT CORP.
K023320 10/04/2002 AGILTRAC .035 PERIPHERAL DILATATION CATHETER GUIDANT CORP.
K033834 12/10/2003 OMNILINK .018 BILIARY STENT SYSTEM GUIDANT CORP.
K971815 05/16/1997 ASC BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDANT CORP.
K965183 12/24/1996 VANTAGE PERIPHERAL DILATATION CATHETER GUIDANT CORP.
K022738 08/19/2002 AGILTRAC .035 PERIPHERAL DILATATION CATHETER GUIDANT CORP.
K030512 02/19/2003 GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM GUIDANT CORP.
K013638 11/05/2001 MODIFICATION TO VIKING OPTIMA GUIDING CATHETER GUIDANT CORP.
K011881 06/18/2001 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP.
K012050 07/02/2001 VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER GUIDANT CORP.
K014007 12/05/2001 DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP.
K014184 12/20/2001 MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP.
K992319 07/12/1999 RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM GUIDANT CORP.
K983075 09/02/1998 GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38 GUIDANT CORP.
K993588 10/22/1999 MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, GUIDANT CORP.
K972484 07/02/1997 ACS VIKING GUIDING CATHETER GUIDANT CORP.
K031459 05/08/2003 RAPIDO CUT-AWAY CUTTER GUIDANT CORP.
K992863 08/25/1999 LEAD STYLET,MODELS 6505,6506,6507,6508 GUIDANT CORP.
K991102 04/01/1999 COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 GUIDANT CORP.
K001435 05/08/2000 VIKING OPTIMA GUIDING CATHETER GUIDANT CORP.
K012002 06/27/2001 VIKING OPTIMA GUIDING CATHETER GUIDANT CORP.
K972290 06/19/1997 ACS HI-TORQUE RULER GUIDE WIRE GUIDANT CORP.
K980119 01/13/1998 ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE GUIDANT CORP.
K982876 08/14/1998 HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 GUIDANT CORP.
K983055 09/01/1998 RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 GUIDANT CORP.
K993639 10/28/1999 RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER GUIDANT CORP.
K002143 07/17/2000 DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP.
K042908 10/21/2004 RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM GUIDANT CORP.
K972142 06/06/1997 ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING GUIDANT CORP.


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