FDA 510(k)

BioCardia 8.5 F Avance Steerable lntroducer

Número K: K190941 · 2019-05-06

Data da decisão2019-05-06

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioCardia 8.5 F Avance Steerable lntroducer is the device name listed in this FDA 510(k) record. The listed applicant is Biocardia, Inc.. It received FDA 510(k) clearance on 2019-05-06 under 510(k) number K190941. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioCardia 8.5 F Avance Steerable lntroducer?

BioCardia 8.5 F Avance Steerable lntroducer is a medical device that received FDA 510(k) clearance on 2019-05-06. The listed applicant is Biocardia, Inc.. The 510(k) number is K190941.

When did BioCardia 8.5 F Avance Steerable lntroducer receive FDA 510(k) clearance?

BioCardia 8.5 F Avance Steerable lntroducer received FDA 510(k) clearance on 2019-05-06, under 510(k) number K190941.

Who is the listed applicant for BioCardia 8.5 F Avance Steerable lntroducer?

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

What is the FDA product code for BioCardia 8.5 F Avance Steerable lntroducer?

The FDA product code for BioCardia 8.5 F Avance Steerable lntroducer is DYB.

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Fonte oficial

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