Medical Device Manufacturer · US , Mchenry , IL

Atrium Medical Corp.

63 submissions · 61 cleared · Since 1981
63
Total
61
Cleared
0
Denied

Atrium Medical Corp. — FDA 510(k) Submissions

Atrium Medical Corp. has submitted 63 FDA 510(k) premarket notifications since 1981, of which 61 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, Mesh, Surgical, Polymeric, Apparatus, Autotransfusion, Bottle, Collection, Vacuum, Prosthesis, Vascular Graft, Of Less Then 6mm Diameter . Use the specialty filter in the sidebar to narrow results.

63 devices
1–25 of 63
EDRAIN CHEST DRAINAGE SYSTEM
K130131 · BTA Pump, Portable,... · General & Plastic Surgery
Feb 2013 41d
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · DSY Prosthesis, Vascular... · Cardiovascular
Aug 2012 29d
C-QUR RPM MESH
K121070 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Apr 2012 17d
CLEARWAY RX NB CATHETER
K113112 · DQY Catheter, Percutaneous · Cardiovascular
Nov 2011 28d
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
K102596 · DSY Prosthesis, Vascular... · Cardiovascular
Oct 2010 26d
CLEARWAY OTW MODEL 85912
K093431 · DQY Catheter, Percutaneous · Cardiovascular
Apr 2010 167d
ATRIUM C-QUR OVT MESH
K100076 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jan 2010 14d
C-QUR V -PATCH MESH
K090909 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jun 2009 64d
ATRIUM PROLITE S MESH
K082748 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jan 2009 117d
EXPRESS CHEST DRAIN
K081718 · KDQ Bottle, Collection, Vacuum · General Hospital
Jul 2008 37d
C-QUR LITE MESH V-PATCH
K080688 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Apr 2008 36d
C-QUR EDGE MESH V-PATCH
K080691 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Apr 2008 36d
PTFE FLIXENE GRADUATED WALL GRAFT
K071923 · DSY Prosthesis, Vascular... · Cardiovascular
Aug 2007 33d
ATRIUM PROLITE ULTRA S MESH
K070192 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Mar 2007 45d
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
K061680 · DQY Catheter, Percutaneous · Cardiovascular
Dec 2006 183d
IVENA VASCULAR PATCH
K060396 · DXZ Patch, Pledget And... · Cardiovascular
May 2006 86d
ATRIUM MEDICAL CORPORATION C-QUR MESH
K050311 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Mar 2006 416d
ATRIUM FLIXENE GRAFT
K060124 · DSY Prosthesis, Vascular... · Cardiovascular
Mar 2006 71d
ADVANTA T-GRAFT
K051332 · DSY Prosthesis, Vascular... · Cardiovascular
Sep 2005 129d
ATRIUM ICAST COVERED STENT
K050814 · JCT Prosthesis, Tracheal,... · General & Plastic Surgery
May 2005 36d
OCEAN CHEST DRAIN
K043582 · KDQ Bottle, Collection, Vacuum · General Hospital
Jan 2005 24d
EXPRESS AND OASIS CHEST DRAIN
K043140 · CAC Apparatus, Autotransfusion · Anesthesiology
Dec 2004 23d
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
K041269 · JCT Prosthesis, Tracheal,... · General & Plastic Surgery
Sep 2004 125d
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K020634 · DXE Catheter, Embolectomy · Cardiovascular
May 2002 70d
ADVANTA SST BIFURCATED GRAFT
K020767 · DSY Prosthesis, Vascular... · Cardiovascular
Apr 2002 26d
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