510(k) · Cleared
ClearedWirion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gardia Medical · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Jun 4, 2015 as substantially equivalent to K063313 (Boston Scientific Corp, 2006) and 1 other predicate after a 169-day review. Its family tree reaches back 6 generations to 2001. 1 of the 15 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jun 4, 2015
- Review
- 169 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003992 (2001). 11 ancestors in all. 3 later devices descend from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 5 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 4 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 3 generations backK051984 Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models…Boston Scientific Corp · 2006
- 2 generations backK061332 Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Boston Scientific Corp · 2006
- 1 generation backK063313 Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp · 2006 · Recalled
- This deviceK143570 WirionGardia Medical · 2015
- Descendant · cites it directly · 2 of its ownK180023 WirionGardia Medical, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK200198 WirionCardiovascular Systems, Inc. · 2020
- Descendant · 3 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 System3 generations on · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −5 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −4 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −3 | K051984 | Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190… | Boston Scientific Corp | 2006 | — |
| −2 | K061332 | Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM) | Boston Scientific Corp | 2006 | — |
| −1 | K063313 | Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM) | Boston Scientific Corp | 2006 | 6 |
| 0 (this device) | K143570 | Wirion | Gardia Medical | 2015 | — |
| +1 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| +2 | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
| +3 | 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 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K063313 | Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Summary page 4…lowing predicates is claimed: 1. FilterWire EZ™ Embolic Protection System; Boston Scientific, cleared under 510(k) number K063313. 2. AngioGuard RX Emboli Capture Guide wire System, Cordis Corporation, a Johnson… | 2006 |
| * | K101651 | Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture GuidewireSummary page 4…ard RX Emboli Capture Guide wire System, Cordis Corporation, a Johnson & Johnson Company, cleared under 510(k) number K101651. Device Description: WIRION™ is a embolic protection System comprised of an independent Filter Unit that can be delivered, locke… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180023 | Wirion | 2018 | 2 |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K180023 (Gardia Medical, Ltd., 2018) has gone furthest, with 2 descendants of its own.
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. 2015, 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 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.
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/K143570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143570: Wirion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143570
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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