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FDA 510(k)

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

K-Number: K192370 · 2019-12-13

ApplicantBayer Medical Care, Inc.
Decision Date2019-12-13
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) 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. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K192370.

When did MEDRAD Stellant FLEX CT Injection System with Certegra Workstation receive FDA 510(k) clearance?

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

Who is the listed applicant for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation?

The FDA 510(k) record lists Bayer Medical Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Bayer Medical Care, Inc. as applicant

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Related Devices (Code: DXT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company LimitedK252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist Medical Systems, Inc.K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.

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.

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