Medical Device Manufacturer · US , Mchenry , IL

Atrium Medical Corp. - FDA 510(k) Cleared Devices

63 submissions · 61 cleared · Since 1981

Recent clearances: EDRAIN CHEST DRAINAGE SYSTEM, ATRIUM FLIXENE IFG VASCULAR GRAFT, C-QUR RPM MESH

63

Total

61

Cleared

0

Denied

FDA 510(k) Regulatory Record - Atrium Medical Corp. Cardiovascular ✕

30 devices

1-12 of 30

Cleared Aug 17, 2012

ATRIUM FLIXENE IFG VASCULAR GRAFT

Cardiovascular · 29d

Cleared Nov 17, 2011

CLEARWAY RX NB CATHETER

Cardiovascular · 28d

Cleared Oct 05, 2010

ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT

Cardiovascular · 26d

Cleared Apr 20, 2010

CLEARWAY OTW MODEL 85912

Cardiovascular · 167d

Cleared Aug 14, 2007

PTFE FLIXENE GRADUATED WALL GRAFT

Cardiovascular · 33d

Cleared Dec 15, 2006

ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER

Cardiovascular · 183d

Cleared May 12, 2006

IVENA VASCULAR PATCH

Cardiovascular · 86d

Cleared Mar 30, 2006

ATRIUM FLIXENE GRAFT

Cardiovascular · 71d

Cleared Sep 29, 2005

ADVANTA T-GRAFT

Cardiovascular · 129d

Cleared May 08, 2002

MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

Cardiovascular · 70d

Cleared Apr 03, 2002

ADVANTA SST BIFURCATED GRAFT

Cardiovascular · 26d

Cleared Jan 25, 2002

ULTRAMAX WOVEN VELOUR VASCULAR GRAFT

Cardiovascular · 88d