HALO60 ABLATION CATHETER


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K112454
Device Name HALO60 ABLATION CATHETER
Applicant
BARRX MEDICAL, INC.
540 oakmead parkway
sunnyvale, 
CA 
94085

Applicant Contact dawn chang
Correspondent
BARRX MEDICAL, INC.
540 oakmead parkway
sunnyvale, 
CA 
94085

Correspodent Contact dawn chang
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Code
KNS  
Date Received 08/25/2011
Decision Date 01/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No