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510(k) K041269

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2004
Date Received
May 12, 2004
Clearance Type
Traditional
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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