510(k) K844854

OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT by Vas-Cath of Canada , Ltd. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1985
Date Received
December 13, 1984
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