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FDA 510(k)

BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER

K-Number: K012913 · 2001-09-28

ApplicantC.R. Bard, Inc.
Decision Date2001-09-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2001-09-28 under 510(k) number K012913. 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 BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER?

BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K012913.

When did BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2001-09-28, under 510(k) number K012913.

Who is the listed applicant for BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER?

The FDA product code for BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER is DQY.

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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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