MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic Cardiac Surgery, Medtronic, Inc. with the FDA for Medtronic Overpressure/vacuum Relief Valve.

Pre-market Notification Details

Device IDK953564
510k NumberK953564
Device Name:MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. 4633 EAST LA PALMA AVE. Anaheim,  CA  92807
ContactWayne R Hohman
CorrespondentWayne R Hohman
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. 4633 EAST LA PALMA AVE. Anaheim,  CA  92807
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-31
Decision Date1996-02-02

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