CRYOCARE CARDIAC SURGICAL SYSTEM


Device Classification Name

surgical device, for ablation of cardiac tissue

510(k) Number K011040
Device Name CRYOCARE CARDIAC SURGICAL SYSTEM
Original Applicant
ENDOCARE, INC.
7 studebaker
irvine, 
CA 
92618

Original Contact vincent cutarelli
Regulation Number 878.4400
Classification Product Code
OCL  
Date Received 04/05/2001
Decision Date 06/15/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No