510(k) K934127

SARNS LOW JETTING AORTIC ARCH CANNULA by 3M Health Care, Sarns — Product Code DWF

K934127 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "SARNS LOW JETTING AORTIC ARCH CANNULA". The FDA issued a decision of Substantially Equivalent on February 22, 1994. 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
February 22, 1994
Date Received
August 25, 1993
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