# K200198: Wirion

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Mar 18, 2020 after 51 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: 9 generations back to K003992 (2001). 23 ancestors in all.
1 later device descends 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)
- K180023: Wirion, Gardia Medical, Ltd. (2018) Summary page 4.

## Most influential descendants
- 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 atherectomy in calcified lesions of the lower extremities. 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/K200198
Methodology: https://510kreport.com/methodology