Home / 510(k) Clearances / K261610

510(k) K261610

Verge™ Microcatheter by Instylla, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2026
Date Received
May 14, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

Other clearances by Instylla, Inc.

  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K253677 — Tembo Embolic System (December 15, 2025)
  • K240873 — TEMBO Embolic System (December 16, 2024)
  • K213632 — Instylla Delivery Kit (February 10, 2022)
  • K210808 — Instylla Microcatheter 1.2 (April 15, 2021)
  • K202544 — Instylla Delivery Kit (January 7, 2021)
  • K200744 — Instylla Microcatheter (April 21, 2020)
  • K191659 — Instylla Delivery Kit (October 10, 2019)
  • K191731 — Instylla Microcatheter (August 13, 2019)

Other clearances for product code KRA

  • K260771 — TruSelect™ 2.6 Microcatheter (May 15, 2026)
  • K250794 — InVera Infusion Device (March 12, 2026)
  • K243534 — Micro Catheter (July 30, 2025)
  • K231821 — XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E2 (November 29, 2023)
  • K231279 — Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3- (July 5, 2023)
  • K231148 — ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (June 20, 2023)
  • K230957 — TriSalus TriNav® LV Infusion System (May 2, 2023)
  • K223139 — Wallaby 017 Micro Catheter (April 25, 2023)
  • K223176 — Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Pl (April 10, 2023)
  • K230636 — Maestro Microcatheter (March 30, 2023)