Baxter Edwards

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FDMay 4, 2000
K981909BAXTER HEMOSTASIS VALVE INTRODUCERSNovember 24, 1998
K980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARJuly 7, 1998
K965137FOGARTY VALVULOTOME MODEL 700091June 4, 1997
K964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)March 27, 1997
K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETERMarch 25, 1996
K9526384.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPEJuly 28, 1995
K944214BAXTER HANDLE MODEL 1150February 10, 1995
K944858BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTSJanuary 5, 1995
K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERMay 24, 1994
K9264334.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45March 23, 1993