# K024118: Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc.
- Decided: Feb 3, 2003 after 49 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010004 (2001). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010004: Flowrider Flow Directed Micro Catheter, Model 105-5065, Micro Therapeutics, Inc. (2001) Summary page 1.

## Most influential descendants
- K034036: Marathon Flow Directed Micro Catheter, Model 105-5055 (2004), 4 descendants of its own
- K093750: Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC Flow Directed Micro Catheter, Reba (2009), 3 descendants of its own
- K210114: Rebar Micro Catheter (2021), 1 descendant of its own
- K243534: Micro Catheter (2025), 0 descendants of its own
- K202318: Marathon Flow Directed Micro Catheter (2020), 0 descendants of its own

## Recalls of this device
- Sep 23, 2011 · Class II · Z-2471-2012: The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.

## Indications for use
The UltraFlowTMHPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.

Source page: https://510kreport.com/device/K024118
Methodology: https://510kreport.com/methodology