Ebony PTA .014 RX Pheripheral Dilatation Catheter— 510(k) K152230

Name: FDA 510(k) clearance K152230
Creator: U.S. Food and Drug Administration
Published: 2015-09-03

Substantially Equivalent

Natec Medical

FDA 510(k) clearance K152230 for Ebony PTA .014 RX Pheripheral Dilatation Catheter, Substantially Equivalent on 2015-09-03. Applicant: Natec Medical. Device class: 2.

Clearance details

Applicant: Natec Medical
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2015-08-07
Decision date: 2015-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Reduit, MU

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIT

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K254212 — NC PTA Balloon Dilatation Catheter2026-09-16
K260304 — WAVE PTA Balloon Catheter2026-05-20
K252512 — Armada 14 NC PTA Catheter2026-02-13
K251915 — Amethyst HP PTA OTW 0.035 Catheter2025-12-18
K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter +5 more2025-04-04

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 →

Recalls naming K152230

K-number listed on FDA's recall record

Z-1362-2016 — USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.Class II·Terminated·Us Endovascular·20160211

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152230.

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