510(k) clearance
ZYLOX Hippo PTA Balloon Dilatation Catheter
- 510(k) number
- K260416
- Applicant
- Zylox Medtech Co., Ltd.
- Decision date
- Sep 21, 2026
- Date received
- Feb 9, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LIT
- Device type
- Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Hangzhou, CN