510(k) · Cleared
Recalled · Class I · 2021WIRION Embolic Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Systems, Inc. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Mar 3, 2021 as substantially equivalent to K200198 (Cardiovascular Systems, Inc., 2020) after a 30-day review. Its family tree reaches back 10 generations to 2001. 1 of the 25 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Mar 3, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- NTE
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 10 generations to K003992 (2001). 24 ancestors in all. No later device cites it as a predicate yet. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 6 generations between
- 3 generations backK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
- 2 generations backK180023 WirionGardia Medical, Ltd. · 2018
- 1 generation backK200198 WirionCardiovascular Systems, Inc. · 2020
- This deviceK210282 WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021
Show all 10 generations
- Root · 10 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 9 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 8 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 7 generations backK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 6 generations backK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 5 generations backK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- 4 generations backK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- 3 generations backK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
- 2 generations backK180023 WirionGardia Medical, Ltd. · 2018
- 1 generation backK200198 WirionCardiovascular Systems, Inc. · 2020
- This deviceK210282 WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −9 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −8 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −7 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −6 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −5 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| −4 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
| −3 | K111010 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2011 | — |
| −2 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| −1 | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
| 0 (this device) | K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NTE device
- #1 K222694 EmPro EPS (EP4514C-190…score 6.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200198 | WirionSummary page 4…Embolic Protection System Regulation Number: 870.1250, Percutaneous Catheter Classification: Class II Product Code: NTE Predicate Device(s): K200198 – WIRION™ Embolic Protection System Device Description: WIRION® is a temporary Embolic Protection System (EPS),… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2021 | Class I | Z-0394-2022 | Device Design | 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 tearing or separating which may result in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 24 ancestors have a recall of any class.
How does its category compare?
All NTE devicesNTE Temporary Carotid Catheter For Embolic Capture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NTE
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NTE
105in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NTE
3in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · NTE
405in 2025
MAUDE reports naming product code NTE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 119 |
| 2008 | 3 | 95 | 6 | 368 |
| 2009 | 3 | 86 | 0 | 343 |
| 2010 | 1 | — | 0 | 294 |
| 2011 | 4 | 105 | 1 | 304 |
| 2012 | 3 | 30 | 0 | 261 |
| 2013 | 0 | — | 0 | 258 |
| 2014 | 1 | — | 0 | 199 |
| 2015 | 3 | 105 | 0 | 148 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 0 | — | 0 | 141 |
| 2018 | 1 | — | 0 | 158 |
| 2019 | 1 | — | 0 | 233 |
| 2020 | 1 | — | 0 | 238 |
| 2021 | 1 | — | 1 (1) | 327 |
| 2022 | 1 | — | 0 | 326 |
| 2023 | 2 | — | 3 | 354 |
| 2024 | 0 | — | 0 | 398 |
| 2025 | 0 | — | 0 | 405 |
| 2026 | 0 | — | 2 (2) | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210282 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210282: WIRION Embolic Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210282
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026