WAVE PTA Balloon Catheter— 510(k) K260304

Name: FDA 510(k) clearance K260304
Creator: U.S. Food and Drug Administration
Published: 2026-05-20

Substantially Equivalent

WAVE Medical AG

FDA 510(k) clearance K260304 for WAVE PTA Balloon Catheter, Substantially Equivalent on 2026-05-20. Applicant: WAVE Medical AG. Device class: 2.

Clearance details

Applicant: WAVE Medical AG
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2026-01-30
Decision date: 2026-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neuhausen Am Rheinfall, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIT

view all

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
K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter +2 more2025-02-27
K241040 — Amethyst HP PTA OTW 0.035 Catheter2024-12-18

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.