MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626

Instruments, Surgical, Cardiovascular

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Myocardial Lead Implant Tool, Model 10626.

Pre-market Notification Details

Device IDK022238
510k NumberK022238
Device Name:MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
ClassificationInstruments, Surgical, Cardiovascular
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis,  MN  55432 -3576
ContactMary Ellen Best
CorrespondentMary Ellen Best
MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis,  MN  55432 -3576
Product CodeDWS  
CFR Regulation Number870.4500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-11
Decision Date2002-10-09
Summary:summary

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