PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS

Catheter, Septostomy

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Pta, Ptv, Atrioseptostomy, Angiographic, Sizing Catheters.

Pre-market Notification Details

Device IDK011557
510k NumberK011557
Device Name:PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
ClassificationCatheter, Septostomy
Applicant NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
ContactNichelle R Laflesh
CorrespondentNichelle R Laflesh
NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
Product CodeDXF  
Subsequent Product CodeDQO
Subsequent Product CodeLIT
CFR Regulation Number870.5175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-21
Decision Date2001-07-12

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