FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K030303
Device Name FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
Original Applicant
CRYOCATH TECHNOLOGIES, INC.
16771 chemin ste marie
kirkland, 

CA

h9h 5h3

Original Contact jean-pierre desmarais
Regulation Number 878.4350
Classification Product Code
GEH  
Date Received 01/29/2003
Decision Date 04/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No