# Baxter Edwards

- Location (FDA's records): Irvine, CA
- FDA decisions: 11 (1993–2000): 11 510(k) clearances
- Product codes: LYK (2), DYG (1), HCG (1), DSY (1), DYB (1), MGZ (1), DTJ (1), KRH (1), MCW (1), FOZ (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 13 (0 its own)
- Recalls linked to its devices: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Intramed Laboratories, Inc.: 2 (https://510kreport.com/company/intramed-laboratories)
- Catheter Research C/O Burditt, Bowles & Radzius: 1 (https://510kreport.com/company/catheter-research-c-o-burditt-bowles-radzius)

## Firms that cite its devices most
- Edwards Lifesciences, LLC: 5 (https://510kreport.com/company/edwards-lifesciences)
- Velocimed, Inc.: 1 (https://510kreport.com/company/velocimed)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Acumen Medical, Inc.: 1 (https://510kreport.com/company/acumen-medical)
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)
- Vena Medical Holdings Corp: 1 (https://510kreport.com/company/vena-medical-holdings)
- Omnisonics Medical Technologies: 1 (https://510kreport.com/company/omnisonics-medical-technologies)
- Ev3, Inc.: 1 (https://510kreport.com/company/ev3)

## Its most-cited devices
- K952638: 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[ (1995), cited by 3
- K981909: Baxter Hemostasis Valve Introducers (1998), cited by 3
- K944858: Baxter Eptfe Externally Supported Vascular Grafts (1995), cited by 2
- K993816: Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD (2000), cited by 2
- K955839: Multi-Med Multi-Lumen Central Venous Catheter (1996), cited by 2
- K940795: Swan-Ganz CC0/SVO2 Thermodilution Catheter (1994), cited by 1

## Recent decisions
- K993816: Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD (May 4, 2000)
- K981909: Baxter Hemostasis Valve Introducers (Nov 24, 1998)
- K980487: Carpenter-Edwards Classic Ring with Duraflo Treatment Models 4425 (Mitral) and 4525 (Tricuspid), Carpenter-Edwards Physm (Jul 7, 1998)
- K965137: Fogarty Valvulotome Model 700091 (Jun 4, 1997)
- K964021: Intramed Side Branch Occlusion (Sbo) System  (700095 and 700099) (Mar 27, 1997)
- K955839: Multi-Med Multi-Lumen Central Venous Catheter (Mar 25, 1996)
- K952638: 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[ (Jul 28, 1995)
- K944214: Baxter Handle Model 1150 (Feb 10, 1995)

Source page: https://510kreport.com/company/baxter-edwards