Company ยท US
Baxter Edwards
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2000. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LYK | Angioscope | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 |
| DTJ | Holder, Heart-Valve, Prosthesis | 1 |
| DYB | Introducer, Catheter | 1 |
| DYG | Catheter, Flow Directed | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| HCG | Device, Neurovascular Embolization | 1 |
| KRH | Ring, Annuloplasty | 1 |
| MCW | Catheter, Peripheral, Atherectomy | 1 |
| MGZ | Valvulotome | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2000 | K993816 | BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD Baxter Edwards | MCW |
| Nov 24, 1998 | K981909 | BAXTER HEMOSTASIS VALVE INTRODUCERS Baxter Edwards | DYB |
| Jul 7, 1998 | K980487 | CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM Baxter Edwards | KRH |
| Jun 4, 1997 | K965137 | FOGARTY VALVULOTOME MODEL 700091 Baxter Edwards | MGZ |
| Mar 27, 1997 | K964021 | INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) Baxter Edwards | HCG |
| Mar 25, 1996 | K955839 | MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER Baxter Edwards | FOZ |
| Jul 28, 1995 | K952638 | 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ Baxter Edwards | LYK |
| Feb 10, 1995 | K944214 | BAXTER HANDLE MODEL 1150 Baxter Edwards | DTJ |
| Jan 5, 1995 | K944858 | BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS Baxter Edwards | DSY |
| May 24, 1994 | K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER Baxter Edwards | DYG |
| Mar 23, 1993 | K926433 | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 Baxter Edwards | LYK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||