Cleared Traditional

Amethyst HP PTA OTW 0.035 Catheter

K241040 · Natec Medical , Ltd. · Cardiovascular
Dec 2024
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K241040 is an FDA 510(k) clearance for the Amethyst HP PTA OTW 0.035 Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Natec Medical , Ltd. (Reduit, MU). The FDA issued a Cleared decision on December 18, 2024, 246 days after receiving the submission on April 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K241040 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2024
Decision Date December 18, 2024
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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