510(k) · Cleared
ClearedFilterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cleared on Apr 10, 2006 as substantially equivalent to K032884 (Boston Scientific Epi, 2004) and 1 other predicate after a 262-day review. Its family tree reaches back 3 generations to 2001. 1 of the 13 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Apr 10, 2006
- Review
- 262 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003992 (2001). 5 ancestors in all. 7 later devices descend from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 2 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 1 generation backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- This deviceK051984 Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models…Boston Scientific Corp · 2006
- Descendant · cites it directly · 6 of its ownK061332 Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Boston Scientific Corp · 2006
- Descendant · 2 generations on · 4 of its ownK063313 Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp · 2006 · Recalled
- Descendant · 3 generations on · 3 of its ownK143570 WirionGardia Medical · 2015
- Descendant · 4 generations on · 2 of its ownK180023 WirionGardia Medical, Ltd. · 2018
- Descendant · 5 generations on · 1 of its ownK200198 WirionCardiovascular Systems, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K210282 WIRION Embolic Protection System6 generations on · 2021
Most influential descendants
Showing 5 of 7 · See all- K061332Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Boston Scientific Corp · 2006 · cites it directly6descendants
- K063313Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp · 2006 · 2 generations on4descendants
- K143570WirionGardia Medical · 2015 · 3 generations on3descendants
- K180023WirionGardia Medical, Ltd. · 2018 · 4 generations on2descendants
- K200198WirionCardiovascular Systems, Inc. · 2020 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −2 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −1 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| 0 (this device) | K051984 | Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190… | Boston Scientific Corp | 2006 | — |
| +1 | K061332 | Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM) | Boston Scientific Corp | 2006 | — |
| +2 | K063313 | Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM) | Boston Scientific Corp | 2006 | 6 |
| +3 | K143570 | Wirion | Gardia Medical | 2015 | — |
| +4 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| +5 | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathSummary page 1…Embolic Protection System is substantially equivalent in design and intended use to the Filter Wire EZ (3.5 mm - 5.5 mm) Embolic Protection System legally marketed under K032884 and to the Medtronic®& PercuSurge Guard Wire Plus® Temporary Occlusion and Aspiration System (K013913) indicated in 2.5 -5.0 mm S… | 2004 |
| * | K013913 | Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemSummary page 1…(3.5 mm - 5.5 mm) Embolic Protection System legally marketed under K032884 and to the Medtronic®& PercuSurge Guard Wire Plus® Temporary Occlusion and Aspiration System (K013913) indicated in 2.5 -5.0 mm SVG vessel diameters. Device Description: The Boston Scientific FilterWire EZ (2.25 mm - 3.5 mm) Embo… | 2002 |
| † | K023691 | Boston Scientific Filterwire EX Embolic | 2003 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061332 | Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM) | 2006 | 6 |
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K061332 (Boston Scientific Corp, 2006) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K032884.
How does its category compare?
All NFA devicesNFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFA
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NFA
Too few NFA 510(k)s in any year since 2007 to give a median.
Recalls per year · NFA
No recall names NFA since 2007.
Adverse event reports per year · NFA
91in 2025
MAUDE reports naming product code NFA, 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 | 110 |
| 2008 | 2 | — | 0 | 80 |
| 2009 | 0 | — | 0 | 104 |
| 2010 | 0 | — | 0 | 183 |
| 2011 | 0 | — | 0 | 45 |
| 2012 | 0 | — | 0 | 55 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 42 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 63 |
| 2017 | 0 | — | 0 | 50 |
| 2018 | 0 | — | 0 | 78 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 55 |
| 2025 | 0 | — | 0 | 91 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FilterWire EZ Tm Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm. · The safety and effectiveness of this device as an embolic protection system has not been…
Read the full statement (127 words)
The FilterWire EZ Tm Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm.
· The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature.
* The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
* The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051984: Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051984
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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