MEDRAD MRXperion MR Injection System And MR Injection System Syringe Kit

Injector And Syringe, Angiographic

Bayer Medical Care Inc.

The following data is part of a premarket notification filed by Bayer Medical Care Inc. with the FDA for Medrad Mrxperion Mr Injection System And Mr Injection System Syringe Kit.

Pre-market Notification Details

Device IDK182276
510k NumberK182276
Device Name:MEDRAD MRXperion MR Injection System And MR Injection System Syringe Kit
ClassificationInjector And Syringe, Angiographic
Applicant Bayer Medical Care Inc. 1 Bayer Drive Indianola,  PA  15051
ContactKatie Dillon
CorrespondentKatie Dillon
Bayer Medical Care Inc. 1 Bayer Drive Indianola,  PA  15051
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-22
Decision Date2018-11-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00616258026206 K182276 000
00616258025094 K182276 000

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