ATRICURE COOLRAIL LINEAR PEN


Device Classification Name

surgical device, for ablation of cardiac tissue

510(k) Number K073605
Device Name ATRICURE COOLRAIL LINEAR PEN
Applicant
ATRICURE, INC.
6033 schumacher park dr.
west chester, 
OH 
45069

Applicant Contact alison grimaldi
Regulation Number 878.4400
Classification Product Code
OCL  
Date Received 12/21/2007
Decision Date 03/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No