MULLINS-X PTV CATHETER

Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Mullins-x Ptv Catheter.

Pre-market Notification Details

Device IDK102473
510k NumberK102473
Device Name:MULLINS-X PTV CATHETER
ClassificationPulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter
Applicant NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
ContactNichelle Laflesh
CorrespondentNichelle Laflesh
NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
Product CodeOMZ  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-30
Decision Date2010-12-09
Summary:summary

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