RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE

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 Vasoplegia Cannula With & Without Check Valve.

Pre-market Notification Details

Device IDK896778
510k NumberK896778
Device Name:RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE
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 Received1989-12-01
Decision Date1990-02-27

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