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.

Summary

WAVE Medical's WAVE PTA Balloon Catheter is filed under LIT, peripheral transluminal angioplasty catheters.

Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).

WAVE Medical filed from Neuhausen Am Rheinfall, Switzerland. Review took 110 calendar days (January 30 to May 20, 2026).

Clearance details

Applicant: WAVE Medical AG
Product code: Product 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

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K260416 — ZYLOX Hippo PTA Balloon Dilatation Catheter2026-09-21
K254212 — NC PTA Balloon Dilatation Catheter2026-09-16
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 →

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