510(k) · Cleared
ClearedWirion
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 18, 2020 as substantially equivalent to K180023 (Gardia Medical, Ltd., 2018) after a 51-day review. Its family tree reaches back 9 generations to 2001. 1 of the 25 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Mar 18, 2020
- Review
- 51 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003992 (2001). 23 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 5 generations between
- 3 generations backK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- 2 generations backK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
- 1 generation backK180023 WirionGardia Medical, Ltd. · 2018
- This deviceK200198 WirionCardiovascular Systems, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK210282 WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 8 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 7 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 6 generations backK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 5 generations backK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 4 generations backK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- 3 generations backK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- 2 generations backK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
- 1 generation backK180023 WirionGardia Medical, Ltd. · 2018
- This deviceK200198 WirionCardiovascular Systems, Inc. · 2020
Class I recalls in this family
- K210282 WIRION Embolic Protection Systemcites it directly · 2021
Most influential descendants
Showing 1 of 1 · See all- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −8 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −7 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −6 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −5 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −4 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| −3 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
| −2 | K111010 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2011 | — |
| −1 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| 0 (this device) | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K180023 | WirionSummary page 4…Embolic Protection System Regulation Number: 870.1250, Percutaneous Catheter Classification: Class II Product Code: NTE Predicate Device(s): K180023 – WIRION™ (Gardia Medical Ltd.) Device Description: WIRION™ is a temporary Embolic Protection System (EPS),… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210282 | WIRION Embolic Protection System Class I | 2021 | 0 |
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 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K210282 (Cardiovascular Systems, Inc., 2021) has gone furthest, with 0 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. 2020, 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 as stated in the FDA summary.
https://510kreport.com/device/K200198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200198: Wirion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200198
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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