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FDA 510(k)

BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER

K-Number: K042553 · 2005-02-17

ApplicantBiocardia, Inc.
Decision Date2005-02-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Biocardia, Inc.. It received FDA 510(k) clearance on 2005-02-17 under 510(k) number K042553. 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 MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER?

BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2005-02-17. The listed applicant is Biocardia, Inc.. The 510(k) number is K042553.

When did BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER receive FDA 510(k) clearance?

BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER received FDA 510(k) clearance on 2005-02-17, under 510(k) number K042553.

Who is the listed applicant for BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER?

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 MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER?

The FDA product code for BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER is DQY.

Related Clinical Trials

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.

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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.

K190941BioCardia 8.5 F Avance Steerable lntroducerK090999BIOCARDIA MORPH SHEATH GUIDEK012749BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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