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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 a medical device manufactured by Creganna Medical Aslo Business AS Cregganna Tactx Medical. It received FDA 510(k) clearance on 2016-07-21 under approval 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. It is manufactured by Creganna Medical Aslo Business AS Cregganna Tactx Medical. The 510(k) number is K152913.

When was GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle approved by the FDA?

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

What company makes GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle?

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle is manufactured by Creganna Medical Aslo Business AS Cregganna Tactx Medical.

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.

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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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