Company ยท US
Guidant Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2006. Name variants (Inc, Corp, punctuation) are merged.
86510(k) clearances (0 in 12 months)
42recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQX | Wire, Guide, Catheter | 27 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 20 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 16 |
| DQY | Catheter, Percutaneous | 14 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 12 |
| DXY | Implantable Pacemaker Pulse-Generator | 8 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 4 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 4 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 4 |
| DRB | Stylet, Catheter | 3 |
| DYB | Introducer, Catheter | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| KRG | Programmer, Pacemaker | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DTD | Pacemaker Lead Adaptor | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| DXC | Clamp, Vascular | 1 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 1 |
| NEY | System, Ablation, Microwave And Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 2006 | K061865 | FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 Guidant Corp. | NEY |
| Jun 22, 2006 | K061453 | HI-TORQUE WHISPER VIEW GUIDE WIRE Guidant Corp. | DQX |
| May 30, 2006 | K060449 | HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE Guidant Corporation | DQX |
| Apr 12, 2006 | K053459 | OMNILINK .035 BILIARY STENT SYSTEM Guidant Corporation | FGE |
| Mar 6, 2006 | K053454 | RX HERCULINK ELITE BILIARY STENT SYSTEM Guidant Corporation | FGE |
| Mar 3, 2006 | K053019 | ACUITY STEERABLE STYLET ACCESSORY Guidant Corporation | DRB |
| Feb 13, 2006 | K052965 | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. Guidant Corporation | DRB |
| Sep 21, 2005 | K052274 | GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 Guidant Corporation | GEI |
| Aug 18, 2005 | K052166 | MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM Guidant Corporation | NTE |
| Aug 16, 2005 | K052165 | RX ACCUNET EMBOLIC PROTECTION SYSTEM Guidant Corporation | NTE |
| Nov 12, 2004 | K042908 | RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM Guidant Corp. | NTE |
| Aug 31, 2004 | K042218 | ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM Guidant Corp. | NTE |
| Aug 20, 2004 | K041981 | GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 Guidant Corporation | GEI |
| Aug 6, 2004 | K041762 | FINISHING WIRE SUPPORTRAK Guidant Corporation | DQX |
| Jul 12, 2004 | K041574 | CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 Guidant Corporation | DTD |
| Mar 3, 2004 | K031903 | RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 Guidant Corporation | DTZ |
| Jan 2, 2004 | K033834 | OMNILINK .018 BILIARY STENT SYSTEM Guidant Corp. | FGE |
| Nov 10, 2003 | K033393 | ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM Guidant Corp. | FGE |
| Oct 23, 2003 | K032530 | MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM Guidant Corporation | FGE |
| Aug 26, 2003 | K031678 | HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. | DQX |
| Jul 23, 2003 | K031459 | RAPIDO CUT-AWAY CUTTER Guidant Corp. | DQY |
| Jul 2, 2003 | K031688 | RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE Guidant Corporation | DTL |
| Jun 25, 2003 | K031505 | RAPIDO CUT-AWAY GUIDING CATHETER Guidant Corporation | DQY |
| May 20, 2003 | K031398 | IS-1 HEMOSTASIS VALVE, MODEL 6799 Guidant Corp. | DTL |
| May 14, 2003 | K030512 | GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM Guidant Corp. | GCJ |
| Jan 24, 2003 | K030019 | MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE Guidant Corp. | DQX |
| Dec 10, 2002 | K023320 | AGILTRAC .035 PERIPHERAL DILATATION CATHETER Guidant Corp. | DQY |
| Nov 12, 2002 | K023627 | ESSEX ENDOSCOPE, MODEL SXD-1000 Guidant Corp. | GCJ |
| Oct 28, 2002 | K023300 | 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. | DQX |
| Sep 13, 2002 | K022880 | GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 Guidant Corp. | DXC |
| Sep 13, 2002 | K022738 | AGILTRAC .035 PERIPHERAL DILATATION CATHETER Guidant Corp. | DQY |
| Aug 2, 2002 | K021455 | RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, Guidant Corp. | DQY |
| Jul 2, 2002 | K021824 | DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 Guidant Corp. | FGE |
| May 15, 2002 | K021228 | HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE Guidant Corp. | DQX |
| May 2, 2002 | K021285 | HI-TORQUE EXTRA S'PORT GUIDEWIRE Guidant Corp. | DQX |
| May 2, 2002 | K021284 | EASYTRAK GUIDING CATHETER Guidant Corp. | DQY |
| May 2, 2002 | K021283 | GUIDANT BALLOON CATHETER, SEVERAL MODELS Guidant Corp. | DQO |
| May 2, 2002 | K021282 | LV-1 HEMOSTASIS VALVE, MODEL #6789 Guidant Corp. | DTL |
| Mar 1, 2002 | K020340 | MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. | DQX |
| Feb 22, 2002 | K020161 | AGILTRAC .018 PERIPHERAL DILATATION CATHETER Guidant Corp. | DQY |
| Jan 18, 2002 | K014184 | MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM Guidant Corp. | FGE |
| Jan 16, 2002 | K013833 | HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 Guidant Corp. | DQX |
| Jan 10, 2002 | K014250 | 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 Guidant Corp. | GCJ |
| Jan 7, 2002 | K014007 | DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM Guidant Corp. | FGE |
| Dec 13, 2001 | K013092 | HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. | DQX |
| Dec 4, 2001 | K013638 | MODIFICATION TO VIKING OPTIMA GUIDING CATHETER Guidant Corp. | DQY |
| Sep 6, 2001 | K012050 | VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER Guidant Corp. | DQY |
| Jul 26, 2001 | K012002 | VIKING OPTIMA GUIDING CATHETER Guidant Corp. | DQY |
| Jul 18, 2001 | K011881 | DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM Guidant Corp. | FGE |
| Jun 15, 2001 | K011506 | OMNILINK .035 BILIARY STENT SYSTEM Guidant Corp. | FGE |
Newest 50 of 86.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy Terminated |
LWP | None listed |
| Oct 12, 2006 | Guidant Corporation Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Gu Terminated |
LWS | None listed |
| Jul 4, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M159), CONTAK RENEWAL 4 AVT (models M170, M175), CONTAK RENEWAL 4 AVT HE (models M177, M179). Cardiac Resynchro Terminated |
LWP | None listed |
| Jul 4, 2006 | Guidant Corporation VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is Terminated |
LWP | None listed |
| Jul 4, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK RENEWAL 4 HE (models H197, H199). Cardiac Resynchronization T Terminated |
NIK | None listed |
| May 23, 2006 | Guidant Corporation VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator) Terminated |
LWP | None listed |
| May 23, 2006 | Guidant Corporation CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 H Terminated |
NIK | None listed |
| May 23, 2006 | Guidant Corporation CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4 Terminated |
NIK | None listed |
| May 16, 2006 | Guidant Corporation CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defib Terminated |
NIK | None listed |
| May 2, 2006 | Guidant Corporation Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This I Terminated |
NIK | None listed |
| May 2, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardi Terminated |
NIK | None listed |
| May 2, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, Terminated |
NIK | None listed |
| May 2, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue Nort Terminated |
NIK | None listed |
| Nov 23, 2005 | Guidant Corporation Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers Terminated |
DXY | None listed |
| Nov 23, 2005 | Guidant Corporation Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) a Terminated |
DXY | None listed |
| Nov 23, 2005 | Guidant Corporation Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) Terminated |
DXY | None listed |
| Nov 23, 2005 | Guidant Corporation Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics N Terminated |
DXY | None listed |
| Sep 24, 2005 | Guidant Corporation Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemake Terminated |
DXY | None listed |
| Sep 24, 2005 | Guidant Corporation Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 13 Terminated |
DXY | None listed |
| Sep 24, 2005 | Guidant Corporation Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model Terminated |
DXY | None listed |
| Sep 24, 2005 | Guidant Corporation Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedi Terminated |
DXY | None listed |
| Aug 30, 2005 | Guidant Corporation Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc Terminated |
DYB | K831751 |
| Aug 30, 2005 | Guidant Corporation Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array. Contains one tunneler and four sheaths. Sterilized with gaseous ethylene oxide. Guidant Corporation, Car Terminated |
DYB | None listed |
| Aug 30, 2005 | Guidant Corporation Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/Defibrillation Lead. Guidant Corporation Cardiac Rhythm Management 4100 Hamline Avenue North, St. Paul, MN Terminated |
DYB | None listed |
| Aug 3, 2005 | Guidant Corporation CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, Terminated |
NIK | None listed |
| Aug 3, 2005 | Guidant Corporation PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue Terminated |
KRG | None listed |
| Jul 28, 2005 | Guidant Corporation CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The Guidan Terminated |
LWP | None listed |
| Jul 28, 2005 | Guidant Corporation INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . INTELIS II pacemakers are multiprogrammable pacemakers from Guida Terminated |
LWP | None listed |
| Jul 28, 2005 | Guidant Corporation VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . VIRTUS PLUS II pacemakers are multiprogrammable pacemakers from Guidant. The family consis Terminated |
LWP | None listed |
| Jul 28, 2005 | Guidant Corporation DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . DISCOVERY II pacemakers are multiprogrammable pacemake Terminated |
LWP | None listed |
| Jul 28, 2005 | Guidant Corporation PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . PULSAR MAX II pacemakers are multiprogrammable pacemakers from Guidant. The family co Terminated |
LWP | None listed |
| Jul 28, 2005 | Guidant Corporation PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamli Terminated |
LWP | None listed |
| Jul 28, 2005 | Guidant Corporation MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-579 Terminated |
LWP | None listed |
| Jul 28, 2005 | Guidant Corporation DISCOVERY (model nos. 1174, 1175, 1273, 1274 and 1275) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5 Terminated |
LWP | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide. Guidant corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac Resynchronization Therapy Defibrillator. Sterile EO. Guidant Corporation, 4100 Hamiline Avenue No Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D (model no. M177 and M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene ox Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 3 AVT CRT-D (model no. M150 and M155) and CONTAK RENEWAL 3 AVT HE CRT-D(model no. M157 and M159) Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONTAK RENEWAL 4 HE CRT-D (model no. H197 and H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Gu Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model no. H177 and H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 41 Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Ha Terminated |
KRG | None listed |