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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
510(k) Number K061593
Device Name ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
Applicant
ATRICURE, INC.
6033 SCHUMACHER PARK DR.
WEST CHESTER,  OH  45069
Applicant Contact ELSA C ABRUZZO
Correspondent
ATRICURE, INC.
6033 SCHUMACHER PARK DR.
WEST CHESTER,  OH  45069
Correspondent Contact ELSA C ABRUZZO
Regulation Number878.4400
Classification Product Code
OCL  
Date Received06/08/2006
Decision Date 07/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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