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FDA 510(k)

Amethyst HP PTA OTW 0.035 Catheter

K-Number: K251915 · 2025-12-18

ApplicantNatec Medical , Ltd.
Decision Date2025-12-18
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Amethyst HP PTA OTW 0.035 Catheter is a medical device manufactured by Natec Medical , Ltd.. It received FDA 510(k) clearance on 2025-12-18 under approval number K251915. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Amethyst HP PTA OTW 0.035 Catheter?

Amethyst HP PTA OTW 0.035 Catheter is a medical device that received FDA 510(k) clearance on 2025-12-18. It is manufactured by Natec Medical , Ltd.. The 510(k) number is K251915.

When was Amethyst HP PTA OTW 0.035 Catheter approved by the FDA?

Amethyst HP PTA OTW 0.035 Catheter received FDA 510(k) clearance on 2025-12-18, under approval number K251915.

What company makes Amethyst HP PTA OTW 0.035 Catheter?

Amethyst HP PTA OTW 0.035 Catheter is manufactured by Natec Medical , Ltd..

What is the FDA product code for Amethyst HP PTA OTW 0.035 Catheter?

The FDA product code for Amethyst HP PTA OTW 0.035 Catheter is LIT.

Other Devices by Natec Medical , Ltd.

K210012Tamarin Blue PTCA RX Dilatation Catheter K220410Ebony HP PTA OTW 0.035 Catheter K241040Amethyst HP PTA OTW 0.035 Catheter

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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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