510(k) · Cleared
ClearedFilterwire EZ Embolic Protection System
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 Nov 7, 2005 as substantially equivalent to K032884 (Boston Scientific Epi, 2004) after a 77-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Nov 7, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003992 (2001). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK052280 Filterwire EZ Embolic Protection SystemBoston Scientific Corp · 2005
- Descendant · cites it directly · 0 of its ownK073523 Interceptor Plus Coronary Filter SystemsMedtronic, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc. · 2008 · cites it directly0descendants
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) | K052280 | Filterwire EZ Embolic Protection System | Boston Scientific Corp | 2005 | — |
| +1 | K073523 | Interceptor Plus Coronary Filter Systems | Medtronic, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
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.
Planning a device in NFA? 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 |
|---|---|---|---|
| * | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathSummary page 1…Mountain View, California 94043 -4655 5.2 Name of Predicate Device Boston Scientific FilterWire EZ Embolic Protection System (K032884) 5.3 Device Description The Boston Scientific FilterWire EZ Embolic Protection System is a temporary intra-va… | 2004 |
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 |
|---|---|---|---|
| K073523 | Interceptor Plus Coronary Filter Systems | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073523 (Medtronic, Inc., 2008) has gone furthest, with 0 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 Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052280: Filterwire EZ Embolic Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052280
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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