NUMED MULLINS X PTA CATHETER

Catheter, Percutaneous

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Mullins X Pta Catheter.

Pre-market Notification Details

Device IDK041093
510k NumberK041093
Device Name:NUMED MULLINS X PTA CATHETER
ClassificationCatheter, Percutaneous
Applicant NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
ContactNichelle Laflesh
CorrespondentNichelle Laflesh
NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-27
Decision Date2004-05-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04046964316586 K041093 000
04046964316562 K041093 000
04046964316548 K041093 000
04046964316524 K041093 000

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