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510(k) K251560

FUBUKI XF-R Neurovascular Long Sheath by Asahi Intecc Co., Ltd. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2025
Date Received
May 21, 2025
Clearance Type
Special
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 Asahi Intecc Co., Ltd.

  • K252011 — CHIKAI Nexus petit (February 2, 2026)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)
  • K243383 — CHIKAI Nexus 014 (April 21, 2025)
  • K243733 — SION blue PLUS (April 2, 2025)
  • K241962 — Crossloop (March 27, 2025)
  • K242597 — CROSSLEAD 0.018inch (March 5, 2025)
  • K241702 — CROSSLEAD 0.014inch (February 6, 2025)
  • K241801 — Tornus ES (December 17, 2024)
  • K241510 — CROSSLEAD Tracker (August 14, 2024)
  • K241158 — ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 (June 25, 2024)

Other clearances for product code QJP

  • 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)
  • K252213 — Bendit17 Microcatheter (December 3, 2025)
  • K251372 — VersaD Delivery Catheter (October 24, 2025)
  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K250960 — DUO Microcatheter (September 8, 2025)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)
  • K251044 — 93 NeuFlex Catheter (May 23, 2025)