RMI NORMOCLUDER CORONARY ARTERY OCCLUDER

Catheter, Intravascular Occluding, Temporary

RESEARCH MEDICAL, INC.

The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Normocluder Coronary Artery Occluder.

Pre-market Notification Details

Device IDK915869
510k NumberK915869
Device Name:RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
ClassificationCatheter, Intravascular Occluding, Temporary
Applicant RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale,  UT  84047
ContactRd Hubbert
CorrespondentRd Hubbert
RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale,  UT  84047
Product CodeMJN  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-31
Decision Date1992-12-08

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