ROTATOR;MALE-MALE, MALE-FEMALE

Heat-exchanger, 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 Rotator;male-male, Male-female.

Pre-market Notification Details

Device IDK932251
510k NumberK932251
Device Name:ROTATOR;MALE-MALE, MALE-FEMALE
ClassificationHeat-exchanger, 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 CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-10
Decision Date1993-08-05

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