ACESSORY PACK

Catheter, Angioplasty, Peripheral, Transluminal

MEDTRONICS INTERVENTIONAL VASCULAR

The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Acessory Pack.

Pre-market Notification Details

Device IDK923638
510k NumberK923638
Device Name:ACESSORY PACK
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
ContactKirk Daly
CorrespondentKirk Daly
MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-21
Decision Date1993-02-08

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