510(k) K994209

STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP by Cobe Cardiovascular, Inc. — Product Code DWF

K994209 is an FDA 510(k) premarket notification submitted by Cobe Cardiovascular, Inc. for the device "STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP". The FDA issued a decision of Substantially Equivalent on June 14, 2000. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Cobe Cardiovascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2000
Date Received
December 14, 1999
Clearance Type
Abbreviated
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