Medical Device Manufacturer · US , Irvine , CA

Baxter Edwards - FDA 510(k) Cleared Devices

11 submissions · 10 cleared · Since 1993

Recent clearances: BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD, BAXTER HEMOSTASIS VALVE INTRODUCERS, CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM

View 11 510(k) Devices ↓

11

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Baxter Edwards Neurology ✕

1 devices

1-1 of 1

Cleared Mar 27, 1997

INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)

Neurology · 171d