510(k) K023622

STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 by Stockert Instrumente GmbH — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2002
Date Received
October 29, 2002
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