RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

RESEARCH MEDICAL, INC.

The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Balloon-occlusive Carotid By-pass Shunt.

Pre-market Notification Details

Device IDK861790
510k NumberK861790
Device Name:RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
ContactMichael N Kelly
CorrespondentMichael N Kelly
RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-09
Decision Date1986-07-21

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