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FDA 510(k)

BioCardia 8F Morph DNA Deflectable Guide Catheter

K-Number: K192774 · 2020-01-07

ApplicantBiocardia
Decision Date2020-01-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BioCardia 8F Morph DNA Deflectable Guide Catheter is a medical device manufactured by Biocardia. It received FDA 510(k) clearance on 2020-01-07 under approval number K192774. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioCardia 8F Morph DNA Deflectable Guide Catheter?

BioCardia 8F Morph DNA Deflectable Guide Catheter is a medical device that received FDA 510(k) clearance on 2020-01-07. It is manufactured by Biocardia. The 510(k) number is K192774.

When was BioCardia 8F Morph DNA Deflectable Guide Catheter approved by the FDA?

BioCardia 8F Morph DNA Deflectable Guide Catheter received FDA 510(k) clearance on 2020-01-07, under approval number K192774.

What company makes BioCardia 8F Morph DNA Deflectable Guide Catheter?

BioCardia 8F Morph DNA Deflectable Guide Catheter is manufactured by Biocardia.

What is the FDA product code for BioCardia 8F Morph DNA Deflectable Guide Catheter?

The FDA product code for BioCardia 8F Morph DNA Deflectable Guide Catheter is DQY.

Related Clinical Trials

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Other Devices by Biocardia

K242169Morph DNA Steerable Introducer Sheath

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, 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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