MODIFICATION TO CARDEON AEGIS CATHETER


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K022174
Device Name MODIFICATION TO CARDEON AEGIS CATHETER
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 07/03/2002
Decision Date 07/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No