MEDRAD Stellant FLEX CT Injection System With Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System With Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA,

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 Stellant Flex Ct Injection System With Certegra Workstation, Medrad Stellant Flex Syringe Kits, Medrad Stellant Ct Injection System With Certegra Workstation, Medrad Stellant Syringe Kits, Medrad Stellant Connector Tubing, P3t Cardiac, P3t Pa,.

Pre-market Notification Details

Device IDK182273
510k NumberK182273
Device Name:MEDRAD Stellant FLEX CT Injection System With Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System With Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA,
ClassificationInjector And Syringe, Angiographic
Applicant Bayer Medical Care Inc. 1 Bayer Drive Indianola,  PA  15051
ContactLisa A. Ewing
CorrespondentLisa A. Ewing
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
00616258026473 K182273 000
00616258025384 K182273 000
00616258025377 K182273 000
40616258026440 K182273 000
40616258024811 K182273 000
40616258024545 K182273 000
40616258024538 K182273 000
00616258022512 K182273 000
00616258027340 K182273 000

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