510(k) K896338

VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA by Voss Medical Products — Product Code DWF

K896338 is an FDA 510(k) premarket notification submitted by Voss Medical Products for the device "VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA". The FDA issued a decision of Substantially Equivalent on May 17, 1990. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Voss Medical Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1990
Date Received
November 3, 1989
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