MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE

Electrode, Pacemaker, Temporary

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 6494 Unipolar Temporary Myocardial Pacing Wire.

Pre-market Notification Details

Device IDK012459
510k NumberK012459
Device Name:MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
ClassificationElectrode, Pacemaker, Temporary
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis,  MN  55432 -3576
ContactTina Benoit
CorrespondentTina Benoit
MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis,  MN  55432 -3576
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-01
Decision Date2001-08-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994365426 K012459 000

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