510(k) K020983

JOSTRA SUCKERS, MODEL JS by Jostra AG — Product Code DWF

K020983 is an FDA 510(k) premarket notification submitted by Jostra AG for the device "JOSTRA SUCKERS, MODEL JS". The FDA issued a decision of Substantially Equivalent on January 30, 2004. 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
January 30, 2004
Date Received
March 27, 2002
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