HALO90 COAGULATION CATHETER

Electrosurgical, Cutting & Coagulation & Accessories

BARRX MEDICAL, INCORPORATED

The following data is part of a premarket notification filed by Barrx Medical, Incorporated with the FDA for Halo90 Coagulation Catheter.

Pre-market Notification Details

Device IDK062723
510k NumberK062723
Device Name:HALO90 COAGULATION CATHETER
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale,  CA  94085
ContactViorica Filimon
CorrespondentViorica Filimon
BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale,  CA  94085
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-12
Decision Date2006-11-09
Summary:summary

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