510(k) · Cleared
ClearedFilter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Epi · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cleared on Aug 6, 2004 as substantially equivalent to K023691 (Boston Scientific Epi, 2003) after a 325-day review. Its family tree reaches back 2 generations to 2001. 3 of the 39 devices in its family, counting itself, have a Class I recall. 35 later devices descend from it.
- Decided
- Aug 6, 2004
- Review
- 325 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003992 (2001). 3 ancestors in all. 35 later devices descend from it, 7 citing it directly. 3 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 1 generation backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- This deviceK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- Descendant · cites it directly · 18 of its ownK052659 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · cites it directly · 14 of its ownK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · 3 generations on · 12 of its ownK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- Descendant · 4 generations on · 10 of its ownK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 35 · See all- K052659Spiderx Embolic Protection DeviceEv3, Inc. · 2006 · cites it directly18descendants
- K053195Spiderx Embolic Protection DeviceEv3, Inc. · 2006 · cites it directly14descendants
- K062201Spiderx Embolic Protection DeviceEv3, Inc. · 2006 · 2 generations on13descendants
- K063785Spiderfx Embolic Protection DeviceEv3, Inc. · 2007 · 3 generations on12descendants
- K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −1 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| 0 (this device) | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| +1 | K052659 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +1 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +2 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +3 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| +4 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 1 |
| 2023 | 2 | 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.
3 devices in this family have 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 |
|---|---|---|---|
| * | K023691 | Boston Scientific Filterwire EX EmbolicSummary page 1…Mountain View, California 94043-4655 5.2 Name of Predicate Device Boston Scientific FilterWire EX Embolic Protection System (K023691) 5.3 Device Description The Boston Scientific FilterWire EZ Embolic Protection System is a temporary intra-va… | 2003 |
What descends from it? (35)
See all 357 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052659 | Spiderx Embolic Protection Device | 2006 | 18 |
| K053195 | Spiderx Embolic Protection Device | 2006 | 14 |
| K051984 | Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300 | 2006 | 7 |
| K063313 | Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM) | 2006 | 4 |
| K082348 | Fibernet Embolic Protection System | 2008 | 1 |
| K052280 | Filterwire EZ Embolic Protection System | 2005 | 1 |
| K051179 | EZ Plus Retrieval Sheath, Model 38899-150 | 2005 | 0 |
Has anything in its family been recalled? (3 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.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K052659 (Ev3, Inc., 2006) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K023691.
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/K032884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032884: Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032884
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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