510(k) K260416
K260416 is an FDA 510(k) premarket notification submitted by Zylox Medtech Co., Ltd. for the device "ZYLOX Hippo PTA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on Sep 21, 2026. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Zylox Medtech Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2026
- Date Received
- Feb 9, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)