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FDA 510(k)

BioCardia 8.5 F Avance Steerable lntroducer

K-Number: K190941 · 2019-05-06

ApplicantBiocardia, Inc.
Decision Date2019-05-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Biocardia, Inc.. The 510(k) number is K190941.

When was BioCardia 8.5 F Avance Steerable lntroducer approved by the FDA?

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

What company makes BioCardia 8.5 F Avance Steerable lntroducer?

BioCardia 8.5 F Avance Steerable lntroducer is manufactured by Biocardia, Inc..

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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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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