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510(k) K000820

AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 by Endosonics Corp. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2000
Date Received
March 13, 2000
Clearance Type
Special
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

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