MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD

Injector And Syringe, Angiographic

MEDRAD, INC.

The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Mct, Mct Plus Injector/medrad Front Load.

Pre-market Notification Details

Device IDK924116
510k NumberK924116
Device Name:MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
ClassificationInjector And Syringe, Angiographic
Applicant MEDRAD, INC. 271 KAPPA DR. Pittsburgh,  PA  15238 -2870
ContactPhilip B Jarvi
CorrespondentPhilip B Jarvi
MEDRAD, INC. 271 KAPPA DR. Pittsburgh,  PA  15238 -2870
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-14
Decision Date1993-01-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00616258010502 K924116 000
40616258010081 K924116 000
00616258010090 K924116 000
40616258010104 K924116 000
00616258005430 K924116 000
00616258005492 K924116 000
00616258005508 K924116 000
10616258007233 K924116 000
10616258007240 K924116 000
10616258007264 K924116 000
00616258007366 K924116 000
10616258007523 K924116 000
00616258007793 K924116 000
00616258010441 K924116 000
40616258024385 K924116 000

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