510(k) K013944

JOSTRA DUAL STAGE VENOUS RETURN CANNULAE by Jostra AG — Product Code DWF

K013944 is an FDA 510(k) premarket notification submitted by Jostra AG for the device "JOSTRA DUAL STAGE VENOUS RETURN CANNULAE". The FDA issued a decision of Substantially Equivalent on February 11, 2002. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Jostra AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2002
Date Received
November 29, 2001
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