Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead

Electrode, Pacemaker, Temporary

Medtronic

The following data is part of a premarket notification filed by Medtronic with the FDA for Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead.

Pre-market Notification Details

Device IDK190716
510k NumberK190716
Device Name:Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
ClassificationElectrode, Pacemaker, Temporary
Applicant Medtronic 1851 East Deere Ave. Santa Ana,  CA  92705
ContactJoven Almazan
CorrespondentJoven Almazan
Medtronic 1851 East Deere Ave. Santa Ana,  CA  92705
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-19
Decision Date2019-08-08

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