# K143570: Wirion

- Pathway: 510(k) (Traditional)
- Applicant: Gardia Medical
- Decided: Jun 4, 2015 after 169 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: 6 generations back to K003992 (2001). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063313: Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM), Boston Scientific Corp (2006) Summary page 4.
- K101651: Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture Guidewire, Cordis Corp. (2010) Summary page 4.

## Most influential descendants
- K180023: Wirion (2018), 2 descendants of its own
- K200198: Wirion (2020), 1 descendant of its own
- K210282: WIRION Embolic Protection System (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K143570
Methodology: https://510kreport.com/methodology