Baxter Edwards - FDA 510(k) Cleared Devices
11
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Baxter Edwards Cardiovascular ✕
9 devices
Cleared
May 04, 2000
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD...
Cardiovascular
176d
Cleared
Nov 24, 1998
BAXTER HEMOSTASIS VALVE INTRODUCERS
Cardiovascular
176d
Cleared
Jul 07, 1998
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL)...
Cardiovascular
148d
Cleared
Jun 04, 1997
FOGARTY VALVULOTOME MODEL 700091
Cardiovascular
163d
Cleared
Jul 28, 1995
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS...
Cardiovascular
49d
Cleared
Feb 10, 1995
BAXTER HANDLE MODEL 1150
Cardiovascular
165d
Cleared
Jan 05, 1995
BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
Cardiovascular
94d
Cleared
May 24, 1994
SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
Cardiovascular
91d
Cleared
Mar 23, 1993
4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45
Cardiovascular
90d