CHECK VALVE (FITTING)

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 Check Valve (fitting).

Pre-market Notification Details

Device IDK933084
510k NumberK933084
Device Name:CHECK VALVE (FITTING)
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 Received1993-06-23
Decision Date1994-03-23

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