RMI POROUS VENT PLUG

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 Porous Vent Plug.

Pre-market Notification Details

Device IDK861322
510k NumberK861322
Device Name:RMI POROUS VENT PLUG
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 Received1986-04-08
Decision Date1986-05-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00690103042115 K861322 000
00690103042108 K861322 000
00690103036206 K861322 000

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