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 IDK213915
510k NumberK213915
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-15
Decision Date2022-01-12

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