FDA 510(k)

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

K-Number: K192370 · 2019-12-13

Decision Date2019-12-13

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is a medical device manufactured by Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2019-12-13 under approval number K192370. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation?

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Bayer Medical Care, Inc.. The 510(k) number is K192370.

When was MEDRAD Stellant FLEX CT Injection System with Certegra Workstation approved by the FDA?

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation received FDA 510(k) clearance on 2019-12-13, under approval number K192370.

What company makes MEDRAD Stellant FLEX CT Injection System with Certegra Workstation?

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is manufactured by Bayer Medical Care, Inc..

What is the FDA product code for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation?

The FDA product code for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is DXT.

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Other Devices by Bayer Medical Care, Inc.

K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit K182273MEDRAD 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, P3T Abdomen, ISI, Connect.CT K173773MEDRAD 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, P3T Abdomen, ISI, Connect.CT K193028MEDRAD Mark 7 Arterion Injection System K200280MEDRAD Imaging Bulk Package Transfer Spike K250893Ball Joint Guide Array (66295)

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Related Devices (Code: DXT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.