Baxter Edwards
Medical device manufacturer in Irvine, CA.
11510(k) clearances
0PMA approvals
0recalls
Device types
- LYK Angioscope 2
- DYG Catheter, Flow Directed 1
- DSY Prosthesis, Vascular Graft, Of 6mm And… 1
- DTJ Holder, Heart-Valve, Prosthesis 1
- FOZ Catheter, Intravascular, Therapeutic… 1
- HCG Device, Neurovascular Embolization 1
- MGZ Valvulotome 1
- KRH Ring, Annuloplasty 1
- DYB Introducer, Catheter 1
- MCW Catheter, Peripheral, Atherectomy 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K993816 | Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FDMCW · Traditional | 05/04/2000SE |
| K981909 | Baxter Hemostasis Valve IntroducersDYB · Traditional | 11/24/1998SE |
| K980487 | Carpenter-Edwards Classic Ring with Duraflo Treatment Models 4425 (Mitral) and 4525…KRH · Traditional | 07/07/1998SE |
| K965137 | Fogarty Valvulotome Model 700091MGZ · Traditional | 06/04/1997SE |
| K964021 | Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)HCG · Traditional | 03/27/1997SE |
| K955839 | Multi-Med Multi-Lumen Central Venous CatheterFOZ · Traditional | 03/25/1996SE |
| K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to AS the…LYK · Traditional | 07/28/1995SE |
| K944214 | Baxter Handle Model 1150DTJ · Traditional | 02/10/1995SE |
| K944858 | Baxter Eptfe Externally Supported Vascular GraftsDSY · Traditional | 01/05/1995ST |
| K940795 | Swan-Ganz CC0/SVO2 Thermodilution CatheterDYG · Traditional | 05/24/1994SE |
| K926433 | 4.5F Imagecath(R) Coronary Angioscope, COV45LYK · Traditional | 03/23/1993SE |