NUMED GHOST II PTA CATHETERS

Catheter, Angioplasty, Peripheral, Transluminal

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Ghost Ii Pta Catheters.

Pre-market Notification Details

Device IDK003972
510k NumberK003972
Device Name:NUMED GHOST II PTA CATHETERS
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
ContactNichell Laflesh
CorrespondentNichell Laflesh
NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-22
Decision Date2001-01-11

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