PASSAGE HEMOSTASIS VALVE

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Passage Hemostasis Valve.

Pre-market Notification Details

Device IDK925419
510k NumberK925419
Device Name:PASSAGE HEMOSTASIS VALVE
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City,  UT  84107
ContactDennis Reigle
CorrespondentDennis Reigle
MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City,  UT  84107
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-27
Decision Date1993-01-22

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