PEDIATRIC ARTERIAL CANNULA


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K023251
Device Name PEDIATRIC ARTERIAL CANNULA
Original Applicant
POLYSTAN A/S
walgerholm 8
vaerlose, 

DK

dk-3500

Original Contact dana olsen
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 09/30/2002
Decision Date 12/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls