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FDA 510(k)

VIDA PTV DILATATON CATHETER

K-Number: K131002 · 2013-07-02

ApplicantC.R. Bard, Inc.
Decision Date2013-07-02
Product CodeOMZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIDA PTV DILATATON 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 2013-07-02 under 510(k) number K131002. 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 VIDA PTV DILATATON CATHETER?

VIDA PTV DILATATON CATHETER is a medical device that received FDA 510(k) clearance on 2013-07-02. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K131002.

When did VIDA PTV DILATATON CATHETER receive FDA 510(k) clearance?

VIDA PTV DILATATON CATHETER received FDA 510(k) clearance on 2013-07-02, under 510(k) number K131002.

Who is the listed applicant for VIDA PTV DILATATON 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 VIDA PTV DILATATON CATHETER?

The FDA product code for VIDA PTV DILATATON 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 LifesciencesK122367BARD PTV DILATATION 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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