510(k) · Cleared
ClearedWirion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gardia Medical, Ltd. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Mar 21, 2018 as substantially equivalent to K111010 (Ev3, Inc., 2011) and 1 other predicate after a 77-day review. Its family tree reaches back 8 generations to 2001. 1 of the 25 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Mar 21, 2018
- Review
- 77 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K003992 (2001). 22 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 7 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 6 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 5 generations backK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 4 generations backK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 3 generations backK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- 2 generations backK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- 1 generation backK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
- This deviceK180023 WirionGardia Medical, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK200198 WirionCardiovascular Systems, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK210282 WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · Recalled (Class I)
Class I recalls in this family
- K210282 WIRION Embolic Protection System2 generations on · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −7 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −6 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −5 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −4 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −3 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| −2 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
| −1 | K111010 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2011 | — |
| 0 (this device) | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| +1 | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
| +2 | K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | 2021 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 1 |
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 6.4 · 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? (2)
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 |
|---|---|---|---|
| * | K111010 | Spiderfx Embolic Protection DeviceSummary page 4…l equivalence to the following predicates is claimed: 1. Primary Predicate: SpiderFX Ev3, cleared under 510(k) number K111010. 2. Reference Device: WIRION™ Embolic Protection System; Gardia Medical, clea… | 2011 |
| * | K143570 | WirionSummary page 4…number K111010. 2. Reference Device: WIRION™ Embolic Protection System; Gardia Medical, cleared under 510(k) number K143570. Device Description: WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locke… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200198 | Wirion | 2020 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K200198 (Cardiovascular Systems, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K111010.
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. 2018, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180023: Wirion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180023
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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