Company ยท US
Guidant Corporation, Cardiac Surgery
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2008. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 |
| MWS | Stabilizer, Heart | 2 |
| NHW | Electrode, Pacing And Cardioversion, Temporary, Epicardial | 2 |
| DXC | Clamp, Vascular | 1 |
| DYB | Introducer, Catheter | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| NEY | System, Ablation, Microwave And Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 8, 2008 | K080169 | HEARTSTRING III PROXIMAL SEAL SYSTEM Guidant Corporation, Cardiac Surgery | DXC |
| Jul 28, 2004 | K041340 | GUIDANT MICROWAVE ABLATION SYSTEM Guidant Corporation, Cardiac Surgery | NEY |
| Feb 20, 2003 | K023630 | ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 Guidant Corporation, Cardiac Surgery | GCJ |
| Feb 14, 2003 | K024071 | GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM Guidant Corporation, Cardiac Surgery | NHW |
| Nov 12, 2002 | K023629 | ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 Guidant Corporation, Cardiac Surgery | GCJ |
| Aug 28, 2002 | K022718 | VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002 Guidant Corporation, Cardiac Surgery | GEI |
| May 24, 2002 | K020701 | SYNCRUS INTERNAL CARDIOVERSION SYSTEM Guidant Corporation, Cardiac Surgery | NHW |
| Feb 20, 2002 | K020143 | VASOVIEW 5 HARVESTING CANNULA Guidant Corporation, Cardiac Surgery | HET |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2007 | Guidant Cardiac Surgery Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100 Terminated |
MWS | None listed |
| Mar 16, 2007 | Guidant Cardiac Surgery Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000. Terminated |
MWS | None listed |
| Aug 24, 2005 | Guidant Cardiac Surgery Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button. Terminated |
DYB | None listed |
| Jul 20, 2004 | Guidant Cardiac Surgery Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000 Terminated |
HET | K020143 |