CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000


Device Classification Name

device, counter-pulsating, external

510(k) Number K022107
Device Name CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
Original Applicant
CARDIOMEDICS, INC.
18872 bardeen ave.
irvine, 
CA 
92612

Original Contact gary clark
Regulation Number 870.5225
Classification Product Code
DRN  
Date Received 06/28/2002
Decision Date 08/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No