BIB Stent Placement Catheter

Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon

NuMED, Inc

The following data is part of a premarket notification filed by Numed, Inc with the FDA for Bib Stent Placement Catheter.

Pre-market Notification Details

Device IDK211134
510k NumberK211134
Device Name:BIB Stent Placement Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal, Dual-balloon
Applicant NuMED, Inc 2880 Main Street Hopkinton,  NY  12965
ContactNichelle Laflesh
CorrespondentNichelle Laflesh
NuMED, Inc 2880 Main Street Hopkinton,  NY  12965
Product CodeNVM  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-16
Decision Date2021-05-27

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