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510(k) K252213

Bendit17 Microcatheter by Bend IT Technologies, Ltd. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2025
Date Received
July 15, 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 Bend IT Technologies, Ltd.

  • K203842 — Bendit21 Microcatheter (April 13, 2022)
  • K200582 — Bendit2.7 Steerable Microcatheter (June 25, 2020)
  • K190126 — Bendit2.7 Steerable Microcatheter (August 22, 2019)

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)
  • K251372 — VersaD Delivery Catheter (October 24, 2025)
  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K250960 — DUO Microcatheter (September 8, 2025)
  • K251560 — FUBUKI XF-R Neurovascular Long Sheath (June 20, 2025)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)
  • K251044 — 93 NeuFlex Catheter (May 23, 2025)