FDA 510(k)

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

Numéro K : K192370 · 2019-12-13

Date de décision2019-12-13

Code produitDXT

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

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Autres dossiers indiquant Bayer Medical Care, Inc. en tant que demandeur

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Dispositifs connexes (Code : DXT)

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Source officielle

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