510(k) K920902

MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA by 3M Health Care, Sarns — Product Code DWF

K920902 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA". The FDA issued a decision of Substantially Equivalent on May 11, 1993. 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 Health Care, Sarns has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1993
Date Received
February 26, 1992
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