Home / 510(k) Clearances / K252508

510(k) K252508

Intri26 Introducer Sheath by Inari Medical, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2025
Date Received
August 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Inari Medical, Inc.

  • K253323 — Protrieve Sheath (October 29, 2025)
  • K250421 — InThrill™ Thrombectomy System (May 12, 2025)
  • K250088 — FlowTriever2 Catheter (March 13, 2025)
  • K241894 — Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (October 15, 2024)
  • K242557 — ClotTriever XL Catheter (41-102) (September 27, 2024)
  • K233069 — Removal System Large Bore 60 cc Syringe (March 26, 2024)
  • K234034 — VenaCore Thrombectomy Catheter (46-101) (February 9, 2024)
  • K233815 — ClotTriever Sheath (December 18, 2023)
  • K233646 — Intri24 Introducer Sheath (52-101) (December 12, 2023)
  • K231108 — Talon Transseptal Sheath (September 27, 2023)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)
  • K252027 — Vertex(TM) Catheter (September 12, 2025)