FDA 510(k) clearance · back to tracker

Amethyst HP PTA OTW 0.035 Catheter

Natec Medical , Ltd. cleared K251915 on 2025-12-18, decision: substantially equivalent

K-number

K251915

Sponsor

Natec Medical , Ltd.

Device

Amethyst HP PTA OTW 0.035 Catheter

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-12-18

Product code

LIT

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1250

Official FDA record

Open K251915on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K251915 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.