CLOSUREFAST RADIOFREQUENCY CATHETER

Electrosurgical, Cutting & Coagulation & Accessories

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Closurefast Radiofrequency Catheter.

Pre-market Notification Details

Device IDK111887
510k NumberK111887
Device Name:CLOSUREFAST RADIOFREQUENCY CATHETER
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant COVIDIEN 15 HAMPSHIRE STREET Mansfield,  MA  02048
ContactDaniel Campion
CorrespondentDaniel Campion
COVIDIEN 15 HAMPSHIRE STREET Mansfield,  MA  02048
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-01
Decision Date2011-09-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169862944 K111887 000
00643169862937 K111887 000
10884521174924 K111887 000
10884521058071 K111887 000
10884521058057 K111887 000
00763000702298 K111887 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.