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510(k) K050814

ATRIUM ICAST COVERED STENT by Atrium Medical Corp. — Product Code JCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2005
Date Received
March 31, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Expandable
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type

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