Zenith Distal Access Long Sheath— 510(k) K253359
Substantially EquivalentSuzhou Zenith Vascular SciTech Limited
FDA 510(k) clearance K253359 for Zenith Distal Access Long Sheath, Substantially Equivalent on 2026-05-22. Applicant: Suzhou Zenith Vascular SciTech Limited. Device class: 2.
Summary
Suzhou Zenith Vascular SciTech's Zenith Distal Access Long Sheath is filed under QJP, percutaneous neurovasculature catheters.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Zenith filed from Suzhou, China. The decision came 234 calendar days after receipt (September 30, 2025 to May 22, 2026).
Clearance details
- Applicant
- Suzhou Zenith Vascular SciTech Limited
- Product code
- Product code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code QJP
view allMore clearances from Suzhou Zenith Vascular SciTech Limited
view allAdverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
Source: openFDA MAUDE database, through . 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.