PACEPATH MODEL 819

Permanent Pacemaker Electrode

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Pacepath Model 819.

Pre-market Notification Details

Device IDK801417
510k NumberK801417
Device Name:PACEPATH MODEL 819
ClassificationPermanent Pacemaker Electrode
Applicant PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-06-16
Decision Date1980-10-23

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