BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K080557
Device Name BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
Applicant
BARRX MEDICAL, INCORPORATED
540 oakmead parkway
sunnyvale, 
CA 
94085

Applicant Contact viorica filimon
Correspondent
BARRX MEDICAL, INCORPORATED
540 oakmead parkway
sunnyvale, 
CA 
94085

Correspodent Contact viorica filimon
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 02/28/2008
Decision Date 04/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No