Z-6 Atrioseptostomy Catheter

Catheter, Septostomy

NuMED, Inc.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Z-6 Atrioseptostomy Catheter.

Pre-market Notification Details

Device IDK211910
510k NumberK211910
Device Name:Z-6 Atrioseptostomy Catheter
ClassificationCatheter, Septostomy
Applicant NuMED, Inc. 2880 Main Street Hopkinton,  NY  12965
ContactNichelle Laflesh
CorrespondentNichelle Laflesh
NuMED, Inc. 2880 Main Street Hopkinton,  NY  12965
Product CodeDXF  
CFR Regulation Number870.5175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2021-07-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04046955718054 K211910 000
04046955718047 K211910 000

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