510(k) K964374

SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT by 3M Healthcare — Product Code DWF

K964374 is an FDA 510(k) premarket notification submitted by 3M Healthcare for the device "SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT". The FDA issued a decision of Substantially Equivalent on June 18, 1997. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. 3M Healthcare has at least 10 other 510(k) clearances on record.

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