Streamline 6495 Bipolar 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 6495 Bipolar Temporary Myocardial Pacing Lead.

Pre-market Notification Details

Device IDK161249
510k NumberK161249
Device Name:Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
ClassificationElectrode, Pacemaker, Temporary
Applicant Medtronic 1801 East Deere Ave Santa Ana,  CA  92705
ContactDebra Taitague
CorrespondentDebra Taitague
Medtronic 1801 East Deere Ave Santa Ana,  CA  92705
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-03
Decision Date2016-08-19
Summary:summary

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