REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES

Stabilizer, Heart, Non-compression, Reprocessed

ASCENT HEALTHCARE SOLUTIONS

The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Medtronic Cardiac Stabilization And Positioning Devices.

Pre-market Notification Details

Device IDK070036
510k NumberK070036
Device Name:REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
ClassificationStabilizer, Heart, Non-compression, Reprocessed
Applicant ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix,  AZ  85044
ContactKatie Bray
CorrespondentKatie Bray
ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix,  AZ  85044
Product CodeNQG  
CFR Regulation Number870.4500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-03
Decision Date2007-08-17
Summary:summary

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