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FDA 510(k)

MULLINS-X PTV CATHETER

K-Number: K102473 · 2010-12-09

ApplicantNuMED, Inc.
Decision Date2010-12-09
Product CodeOMZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MULLINS-X PTV CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2010-12-09 under 510(k) number K102473. 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 MULLINS-X PTV CATHETER?

MULLINS-X PTV CATHETER is a medical device that received FDA 510(k) clearance on 2010-12-09. The listed applicant is NuMED, Inc.. The 510(k) number is K102473.

When did MULLINS-X PTV CATHETER receive FDA 510(k) clearance?

MULLINS-X PTV CATHETER received FDA 510(k) clearance on 2010-12-09, under 510(k) number K102473.

Who is the listed applicant for MULLINS-X PTV CATHETER?

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

What is the FDA product code for MULLINS-X PTV CATHETER?

The FDA product code for MULLINS-X PTV 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.K122367BARD PTV DILATATION CATHETERC.R. Bard, 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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