Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter— 510(k) K260686

Name: FDA 510(k) clearance K260686
Creator: U.S. Food and Drug Administration
Published: 2026-10-22

Substantially Equivalent

Zylox Medtech Co., Ltd.

FDA 510(k) clearance K260686 for Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter, Substantially Equivalent on 2026-10-22. Applicant: Zylox Medtech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zylox Medtech Co., Ltd.
Product code: Product code PNO
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2026-03-03
Decision date: 2026-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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K243944 — Aperta NSE PTA Balloon Dilatation Catheter2025-04-22
K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter2025-04-21
K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter2024-10-22

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K260416 — ZYLOX Hippo PTA Balloon Dilatation Catheter2026-09-21

Adverse events under product code PNO

product code PNO

Malfunction: 1,646
Total: 1,646

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.