MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K022042
Device Name MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
Original Applicant
CARDEON CORP.
10161 bubb rd.
cupertino, 
CA 
95014 -4133

Original Contact jane beggs
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 06/24/2002
Decision Date 09/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No