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Atrium Medical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
63
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K130131EDRAIN CHEST DRAINAGE SYSTEMFebruary 28, 2013
K122138ATRIUM FLIXENE IFG VASCULAR GRAFTAugust 17, 2012
K121070C-QUR RPM MESHApril 26, 2012
K113112CLEARWAY RX NB CATHETERNovember 17, 2011
K102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTOctober 5, 2010
K093431CLEARWAY OTW MODEL 85912April 20, 2010
K100076ATRIUM C-QUR OVT MESHJanuary 26, 2010
K090909C-QUR V -PATCH MESHJune 4, 2009
K082748ATRIUM PROLITE S MESHJanuary 14, 2009
K081718EXPRESS CHEST DRAINJuly 25, 2008
K080688C-QUR LITE MESH V-PATCHApril 16, 2008
K080691C-QUR EDGE MESH V-PATCHApril 16, 2008
K071923PTFE FLIXENE GRADUATED WALL GRAFTAugust 14, 2007
K070192ATRIUM PROLITE ULTRA S MESHMarch 8, 2007
K061680ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETERDecember 15, 2006
K060396IVENA VASCULAR PATCHMay 12, 2006
K050311ATRIUM MEDICAL CORPORATION C-QUR MESHMarch 31, 2006
K060124ATRIUM FLIXENE GRAFTMarch 30, 2006
K051332ADVANTA T-GRAFTSeptember 29, 2005
K050814ATRIUM ICAST COVERED STENTMay 6, 2005