Home / 510(k) Clearances / K231279

510(k) K231279

Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm by Ablative Solutions, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2023
Date Received
May 3, 2023
Clearance Type
Traditional
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 Ablative Solutions, Inc.

  • K140637 — PEREGRINE SYSTEM INFUSION CATHETER (March 26, 2014)

Other clearances for product code KRA

  • 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)
  • 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)
  • K222679 — Vericor Support Catheter (November 7, 2022)
  • K213435 — MAGIC Flow-Dependent Microcatheter (July 19, 2022)