# K161152: Navien Intracranial Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Oct 12, 2016 after 170 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: 1 generation back to K110055 (2011). 1 ancestor in all.
29 later devices descend from it; 2 cite it directly.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110055: Reverse Medical Reflex Guide Catheter, Reverse Medical Corporation (2011) Summary page 4.

## Most influential descendants
- 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 (2018), 27 descendants of its own
- 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

## Indications for use
The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Source page: https://510kreport.com/device/K161152
Methodology: https://510kreport.com/methodology