PACEMAKER LEAD ADAPTOR MODEL 431

Pacemaker Lead Adaptor

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Pacemaker Lead Adaptor Model 431.

Pre-market Notification Details

Device IDK802407
510k NumberK802407
Device Name:PACEMAKER LEAD ADAPTOR MODEL 431
ClassificationPacemaker Lead Adaptor
Applicant PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTD  
CFR Regulation Number870.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-03
Decision Date1980-10-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.