510(k) K253359
K253359 is an FDA 510(k) premarket notification submitted by Suzhou Zenith Vascular SciTech Limited for the device "Zenith Distal Access Long Sheath". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), a Class II device regulated under 21 CFR 870.1250. Suzhou Zenith Vascular SciTech Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2026
- Date Received
- September 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous, Neurovasculature
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- NE
- Submission Type
To provide vascular access to the neurovasculature for interventional or diagnostic procedures