# K210282: WIRION Embolic Protection System

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Mar 3, 2021 after 30 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K003992 (2001). 24 ancestors in all.
No later device cites it as a predicate yet.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200198: Wirion, Cardiovascular Systems, Inc. (2020) Summary page 4.

## Recalls of this device
- Nov 22, 2021 · Class I · Z-0394-2022: Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tea

## 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/K210282
Methodology: https://510kreport.com/methodology