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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-16
Decision Date2021-05-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04046955719259 K211134 000
04046955718597 K211134 000
04046955718603 K211134 000
04046955718610 K211134 000
04046955718627 K211134 000
04046955718634 K211134 000
04046955718641 K211134 000
04046955718658 K211134 000
04046955718665 K211134 000
04046955718672 K211134 000
04046955718689 K211134 000
04046955718696 K211134 000
04046955718702 K211134 000
04046955718719 K211134 000
04046955718726 K211134 000
04046955718733 K211134 000
04046955718740 K211134 000
04046955718580 K211134 000

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