DEKNATEL TEMPORARY CARDIAC PACING WIRE

Electrode, Pacemaker, Temporary

DEKNATEL, INC.

The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Deknatel Temporary Cardiac Pacing Wire.

Pre-market Notification Details

Device IDK873728
510k NumberK873728
Device Name:DEKNATEL TEMPORARY CARDIAC PACING WIRE
ClassificationElectrode, Pacemaker, Temporary
Applicant DEKNATEL, INC. 2300 MARCUS AVE. Lake Success,  NY  11042
ContactOrofino
CorrespondentOrofino
DEKNATEL, INC. 2300 MARCUS AVE. Lake Success,  NY  11042
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-16
Decision Date1987-11-03

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