DISPOSABLE CORONARY CONTROL SYRINGE 12CC

Injector And Syringe, Angiographic

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Disposable Coronary Control Syringe 12cc.

Pre-market Notification Details

Device IDK875196
510k NumberK875196
Device Name:DISPOSABLE CORONARY CONTROL SYRINGE 12CC
ClassificationInjector And Syringe, Angiographic
Applicant MERIT MEDICAL SYSTEMS, INC. P.O. BOX 17484 Salt Lake City,  UT  84117
ContactFred Lampropoulos
CorrespondentFred Lampropoulos
MERIT MEDICAL SYSTEMS, INC. P.O. BOX 17484 Salt Lake City,  UT  84117
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-17
Decision Date1988-02-11

NIH GUDID Devices

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