TYSHAK, MODEL 102 AND Z-MED, MODEL 302

Catheter, Angioplasty, Peripheral, Transluminal

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Tyshak, Model 102 And Z-med, Model 302.

Pre-market Notification Details

Device IDK991977
510k NumberK991977
Device Name:TYSHAK, MODEL 102 AND Z-MED, MODEL 302
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
ContactNichelle Laflesh
CorrespondentNichelle Laflesh
NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-11
Decision Date2000-09-27
Summary:summary

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