# K093750: Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC Flow Directed Micro Catheter, Reba

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Dec 9, 2009 after 2 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K974473 (1998). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993672: Rebar Micro Catheter, Models 105-5080, 105-5086, Micro Therapeutics, Inc. (2000) Summary page 1.
- K001966: Rebar Micro Catheter: Rebar-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and 153 CM, Dual Marker Band, Micro Therapeutics, Inc. (2000) Summary page 1.
- K002723: Rebar Micro Catheter: Rebar-10 (1.7F), 153 CM, Dual Marker Bands; Rebar Micro Catheter: Rebar-10 (1.7F), 170 CM, Dual MA, Micro Therapeutics, Inc. (2000) Summary page 1.
- K024118: Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066, Micro Therapeutics, Inc. (2003) Summary page 1.
- K024122: Nautica Micro Catheter, Model 105-5094-153, Micro Therapeutics, Inc. (2003) Summary page 1.
- K034036: Marathon Flow Directed Micro Catheter, Model 105-5055, Micro Therapeutics, Inc. (2004) Summary page 1.
- K030688: Echelon Micro Catheter, Model 105-5092-150, Micro Therapeutics, Inc. (2003) Summary page 1.
- K031992: Echelon Micro Catheter, Model 105-5091, Micro Therapeutics, Inc. (2003) Summary page 1.
- K042187: Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon 14,45 Tip Shape Micro Catheter,90, Micro Therapeutics, Inc. (2004) Summary page 1.
- K051990: Echelon Micro Catheter, Micro Therapeutics, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- Jun 30, 2022 · Class II · Z-1556-2022: Outer carton packaging of microcatheters were exposed to wet substance during transport.
- Jun 30, 2022 · Class II · Z-1557-2022: Outer carton packaging of microcatheters were exposed to wet substance during transport.

## Indications for use
The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy. The UltraFlow HPC 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. The Nautica Micro Catheter is intended to access peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature. The Marathon 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. The EchelonTM 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.

Source page: https://510kreport.com/device/K093750
Methodology: https://510kreport.com/methodology