BARRX CHANNEL RFA ENDOSCOPIC CATHETER

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Barrx Channel Rfa Endoscopic Catheter.

Pre-market Notification Details

Device IDK130623
510k NumberK130623
Device Name:BARRX CHANNEL RFA ENDOSCOPIC CATHETER
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Covidien LLC 15 HAMPSHIRE ST Mansfield,  MA  02048
ContactRichelle Hover
CorrespondentRichelle Hover
Covidien LLC 15 HAMPSHIRE ST Mansfield,  MA  02048
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-08
Decision Date2013-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521176621 K130623 000
20884521176611 K130623 000
10884521581753 K130623 000

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