# K180023: Wirion

- Pathway: 510(k) (Traditional)
- Applicant: Gardia Medical, Ltd.
- Decided: Mar 21, 2018 after 77 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- 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 K003992 (2001). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111010: Spiderfx Embolic Protection Device, Ev3, Inc. (2011) Summary page 4.
- K143570: Wirion, Gardia Medical (2015) Summary page 4.

## Most influential descendants
- K200198: Wirion (2020), 1 descendant of its own
- K210282: WIRION Embolic Protection System (2021), 0 descendants of its own

## Indications for use
WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

Source page: https://510kreport.com/device/K180023
Methodology: https://510kreport.com/methodology