510(k) K964373

SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT by 3M Healthcare — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1997
Date Received
November 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type