CARDIMA ABLATION SYSTEM


Device Classification Name

surgical device, for ablation of cardiac tissue

510(k) Number K022008
Device Name CARDIMA ABLATION SYSTEM
Original Applicant
CARDIMA, INC.
25 hartford ave.
san carlos, 
CA 
94070

Original Contact robert a chin
Regulation Number 878.4400
Classification Product Code
OCL  
Date Received 06/19/2002
Decision Date 01/29/2003
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

Recalls CDRH Recalls