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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 the device name listed in this FDA 510(k) record. The listed applicant is Natec Medical , Ltd.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) 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. The listed applicant is Natec Medical , Ltd.. The 510(k) number is K251915.

When did Amethyst HP PTA OTW 0.035 Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Amethyst HP PTA OTW 0.035 Catheter?

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

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 records listing Natec Medical , Ltd. as applicant

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.

K241040Amethyst HP PTA OTW 0.035 CatheterK220410Ebony HP PTA OTW 0.035 CatheterK210012Tamarin Blue PTCA RX Dilatation Catheter

Related Devices (Code: LIT)

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.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, 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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