ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066— 510(k) K024118

Clearance details

Applicant

Micro Therapeutics, Inc.

Product code

Code KRA

Device class

Class 2

Regulation

21 CFR 870.1210

Advisory panel

Cardiovascular

Date received

2002-12-16

Decision date

2003-02-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Irvine, CA, US

• K254051 — Extroducer Infusion Catheter System2026-09-11
• K261610 — Verge Microcatheter2026-06-11
• K260771 — TruSelect 2.6 Microcatheter2026-05-15
• K250794 — InVera Infusion Device2026-03-12
• K243534 — Micro Catheter2025-07-30

• K113289 — ORION MICRO CATHETER2012-08-01
• K113454 — 14 WIRE STANDARD, 14 WIRE LS2012-02-24
• K090870 — ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY2009-05-01
• K090046 — CONCERTO DETACHABLE COIL SYSTEM2009-02-27
• K081465 — AXIUM DETACHABLE COIL SYSTEM2008-08-19

Death

234

Injury

1,029

Malfunction

3,012

Other

2

Total

4,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2471-2012 — UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.Class II·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·20110923

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024118.