D'Vill Introducer

Introducer, Catheter

NuMED, Inc.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for D'vill Introducer.

Pre-market Notification Details

Device IDK171206
510k NumberK171206
Device Name:D'Vill Introducer
ClassificationIntroducer, Catheter
Applicant NuMED, Inc. 2880 Main Street Hopkinton,  NY  12965
ContactNichelle Laflesh
CorrespondentNichelle Laflesh
NuMED, Inc. 2880 Main Street Hopkinton,  NY  12965
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-25
Decision Date2017-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04046955128297 K171206 000
04046955128280 K171206 000
04046955128273 K171206 000
04046955128266 K171206 000
04046955128259 K171206 000
04046955127702 K171206 000

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