510(k) · Cleared
ClearedFilterwire EZ Embolic Protection System (2.25 MM-3.5 MM)
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 Aug 11, 2006 as substantially equivalent to K051984 (Boston Scientific Corp, 2006) after a 91-day review. Its family tree reaches back 4 generations to 2001. 1 of the 13 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Aug 11, 2006
- Review
- 91 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003992 (2001). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 3 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 2 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 1 generation backK051984 Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models…Boston Scientific Corp · 2006
- This deviceK061332 Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Boston Scientific Corp · 2006
- Descendant · cites it directly · 4 of its ownK063313 Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp · 2006 · Recalled
- Descendant · 2 generations on · 3 of its ownK143570 WirionGardia Medical · 2015
- Descendant · 3 generations on · 2 of its ownK180023 WirionGardia Medical, Ltd. · 2018
- Descendant · 4 generations on · 1 of its ownK200198 WirionCardiovascular Systems, Inc. · 2020
- Descendant · 5 generations on · 0 of its ownK210282 WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · Recalled (Class I)
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K210282 WIRION Embolic Protection System5 generations on · 2021
Most influential descendants
Showing 5 of 6 · See all- K063313Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp · 2006 · cites it directly4descendants
- K143570WirionGardia Medical · 2015 · 2 generations on3descendants
- K180023WirionGardia Medical, Ltd. · 2018 · 3 generations on2descendants
- K200198WirionCardiovascular Systems, Inc. · 2020 · 4 generations on1descendant
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −3 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −2 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −1 | K051984 | Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190… | Boston Scientific Corp | 2006 | — |
| 0 (this device) | 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 |
| +2 | K143570 | Wirion | Gardia Medical | 2015 | — |
| +3 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| +4 | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
| +5 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K051984 | Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300Summary page 2…mm) indicated for use in saphenous vein bypass grafts is equivalent to the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984 in that the intended use, principles of operation, design and materials are similar. The following design a… | 2006 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 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 6 ancestors has a recall.
- Of its descendants, K063313 (Boston Scientific Corp, 2006) has gone furthest, with 4 descendants of its own.
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 indications for use for the FilterWire EZ Embolic Protection System are as follows:
The FilterWire EZ 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 artery 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 cerebral, carotid and peripheral vasculature or in treating native coronaries, including acute myocardial infarction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061332 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061332: Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061332
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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