HALO ABLATION CATHETER, MODEL 90-9100

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 Halo Ablation Catheter, Model 90-9100.

Pre-market Notification Details

Device IDK093008
510k NumberK093008
Device Name:HALO ABLATION CATHETER, MODEL 90-9100
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-28
Decision Date2010-01-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521189362 K093008 000
20884521189390 K093008 000

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