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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tracheal, Expandable
510(k) Number K050814
Device Name ATRIUM ICAST COVERED STENT
Applicant
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Applicant Contact JOSEPH P PAOLO
Correspondent
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Correspondent Contact JOSEPH P PAOLO
Regulation Number878.3720
Classification Product Code
JCT  
Date Received03/31/2005
Decision Date 05/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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