Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 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 Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead.

Pre-market Notification Details

Device IDK171253
510k NumberK171253
Device Name:Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
ClassificationElectrode, Pacemaker, Temporary
Applicant Medtronic 1851 East Deere Ave Santa Ana,  CA  92705
ContactDebra Taitague
CorrespondentDebra Taitague
Medtronic 1851 East Deere Ave Santa Ana,  CA  92705
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-28
Decision Date2017-05-25
Summary:summary

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