Amethyst HP PTA OTW 0.035 Catheter— 510(k) K251915

Substantially Equivalent

Natec Medical , Ltd.

FDA 510(k) clearance K251915 for Amethyst HP PTA OTW 0.035 Catheter, Substantially Equivalent on 2025-12-18. Applicant: Natec Medical , Ltd..

Clearance details

Applicant: Natec Medical , Ltd.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2025-06-23
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moka, MU

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.