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510(k) K253359

Zenith Distal Access Long Sheath by Suzhou Zenith Vascular SciTech Limited — Product Code QJP

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

Other clearances by Suzhou Zenith Vascular SciTech Limited

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  • K252317 — Zenith Micro Guidewire (April 16, 2026)
  • K243534 — Micro Catheter (July 30, 2025)

Other clearances for product code QJP

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  • K254178 — SAYA 86 Radial Access Guide Catheter (May 11, 2026)
  • K254046 — BosCATH Support Catheter (April 21, 2026)
  • K254223 — Next Generation 088 Catheter (April 16, 2026)
  • K260938 — PATH BGC (April 15, 2026)
  • K253975 — Radical 6F Access Catheter (April 9, 2026)
  • K253032 — AXS Lift Intracranial Base Catheter (February 11, 2026)
  • K252297 — Toro 88 Superbore Catheter (January 16, 2026)
  • K251097 — V-DAC Catheter (January 6, 2026)
  • K251668 — SurfRider 13 Microcatheter (January 5, 2026)