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510(k) K984627

AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER by Arterial Vascular Engineering, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1999
Date Received
December 30, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Arterial Vascular Engineering, Inc.

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  • K971295 — AVE BRIDGE STENT SYSTEM (November 5, 1997)

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