ROTATING ADAPTERS

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 Rotating Adapters.

Pre-market Notification Details

Device IDK140475
510k NumberK140475
Device Name:ROTATING ADAPTERS
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactCory Marsh
CorrespondentCory Marsh
MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-26
Decision Date2014-04-16
Summary:summary

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