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 IDK161451
510k NumberK161451
Device Name:BIB Stent Placement Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal, Dual-balloon
Applicant NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
ContactNichelle Laflesh
CorrespondentNichelle Laflesh
NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
Product CodeNVM  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-26
Decision Date2016-09-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04046955049004 K161451 000
04046955048991 K161451 000
04046955048984 K161451 000
04046955048977 K161451 000
04046955048960 K161451 000
04046955048953 K161451 000
04046955048946 K161451 000
04046955048939 K161451 000
04046955048922 K161451 000

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