# Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter (K260686): 510(k) cleared for Zylox Medtech Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 54/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260686 |
| Device | Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter |
| Applicant | Zylox Medtech Co., Ltd. |
| Specialty / panel | Cardiovascular |
| Product code | PNO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-03 |
| Decision date | 2026-10-22 |
| Review time (days) | 233 |
| Third-party review | No |
| Applicant location | Hangzhou, CN |

## Why this score
- 233-day review, longer than typical.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260686). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.