# K170664: Odyssey Micro Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical Components, LLC
- Decided: Nov 9, 2017 after 248 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001992 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151103: ASAHI Corsair Microcatheter, Asahi Intecc Co., Ltd. (2015) Summary page 4.

## Indications for use
The Odyssey Micro Catheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Odyssey Micro Catheter is also intended to assist in the infusion of contrast media. The micro catheter is not intended to be used in the neurovasculature.

Source page: https://510kreport.com/device/K170664
Methodology: https://510kreport.com/methodology