# K113289: Orion Micro Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Aug 1, 2012 after 268 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945904 (1995). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 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.
- K021591: Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips, Cordis Neurovascular, Inc. (2002) Summary page 1.

## Most influential descendants
- K150894: VIA 21 Microcatheter (2015), 2 descendants of its own
- K162565: VIA 17 Microcatheter (2017), 1 descendant of its own
- K192135: VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) (2019), 0 descendants of its own

## Indications for use
The Orion TM Micro Catheter device is intended for the controlled selective infusion of physician-specified therapeutics agents or contrast media into the vasculature of the peripheral and neuro anatomy.

Source page: https://510kreport.com/device/K113289
Methodology: https://510kreport.com/methodology