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FDA 510(k)

BARD PTV DILATATION CATHETER

K-Number: K122367 · 2012-11-02

ApplicantC.R. Bard, Inc.
Decision Date2012-11-02
Product CodeOMZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BARD PTV 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 2012-11-02 under 510(k) number K122367. The device is classified under product code OMZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD PTV DILATATION CATHETER?

BARD PTV DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2012-11-02. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K122367.

When did BARD PTV DILATATION CATHETER receive FDA 510(k) clearance?

BARD PTV DILATATION CATHETER received FDA 510(k) clearance on 2012-11-02, under 510(k) number K122367.

Who is the listed applicant for BARD PTV 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 PTV DILATATION CATHETER?

The FDA product code for BARD PTV DILATATION CATHETER is OMZ.

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Related Devices (Code: OMZ)

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.

K153069Edwards Balloon CatheterEdwards LifesciencesK131002VIDA PTV DILATATON CATHETERC.R. Bard, Inc.K102473MULLINS-X PTV CATHETERNuMED, Inc.K014124NUMED COEFFICIENT PTV CATHETERSNuMED, 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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