FDA 510(k)

BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664

K-Number: K012749 · 2002-01-24

Decision Date2002-01-24

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 is the device name listed in this FDA 510(k) record. The listed applicant is Biocardia, Inc.. It received FDA 510(k) clearance on 2002-01-24 under 510(k) number K012749. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664?

BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 is a medical device that received FDA 510(k) clearance on 2002-01-24. The listed applicant is Biocardia, Inc.. The 510(k) number is K012749.

When did BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 receive FDA 510(k) clearance?

BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 received FDA 510(k) clearance on 2002-01-24, under 510(k) number K012749.

Who is the listed applicant for BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664?

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 UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664?

The FDA product code for BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 is DQO.

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Other records listing Biocardia, Inc. as applicant

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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.