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FDA 510(k)

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

K-Number: K152913 · 2016-07-21

ApplicantCreganna Medical Aslo Business AS Cregganna Tactx Medical
Decision Date2016-07-21
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle is the device name listed in this FDA 510(k) record. The listed applicant is Creganna Medical Aslo Business AS Cregganna Tactx Medical. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K152913. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle?

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Creganna Medical Aslo Business AS Cregganna Tactx Medical. The 510(k) number is K152913.

When did GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle receive FDA 510(k) clearance?

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle received FDA 510(k) clearance on 2016-07-21, under 510(k) number K152913.

Who is the listed applicant for GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle?

The FDA 510(k) record lists Creganna Medical Aslo Business AS Cregganna Tactx Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle?

The FDA product code for GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle is DYB.

Other records listing Creganna Medical Aslo Business AS Cregganna Tactx Medical as applicant

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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.

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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.

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