Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Other records listing Biocardia, Inc. as applicant

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.

K242169Morph DNA Steerable Introducer SheathK192774BioCardia 8F Morph DNA Deflectable Guide Catheter

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

↑