510(k) K002273

STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE by Stoeckert Instrumente — Product Code DWF

K002273 is an FDA 510(k) premarket notification submitted by Stoeckert Instrumente for the device "STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE". The FDA issued a decision of Substantially Equivalent on January 29, 2001. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Stoeckert Instrumente has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2001
Date Received
July 26, 2000
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