# K180169: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length

- Pathway: 510(k) (Traditional)
- Applicant: Imperative Care, Inc.
- Decided: Aug 8, 2018 after 198 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: 6 generations back to K010954 (2001). 11 ancestors in all.
27 later devices descend from it; 3 cite it directly.
2 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111380: Neuron Max System, Penumbra, Inc. (2011) Summary page 4.
- K150107: Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter, Micro Therapeutics Inc Dba Ev3 Neurovascular (2015) Summary page 4.
- K161152: Navien Intracranial Support Catheter, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2016) Summary page 4.

## Most influential descendants
- K203764: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform (2021), 17 descendants of its own
- K200121: Route 92 Medical 088 Access System, 110 cm (2020), 8 descendants of its own
- K214048: Millipede 088 Access Catheter (2022), 6 descendants of its own
- K212224: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform (2021), 6 descendants of its own
- K231802: Millipede 088 Access Catheter (2023), 5 descendants of its own

## Indications for use
The EagleRay Long Sheath and EagleRay Access Catheter are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K180169
Methodology: https://510kreport.com/methodology