510(k) · Cleared
Recalled · 2008Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Dec 5, 2006 as substantially equivalent to K032884 (Boston Scientific Epi, 2004) and 2 other predicates after a 33-day review. Its family tree reaches back 5 generations to 2001. 1 of the 13 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 5, 2006
- Review
- 33 days
- Class
- Class II
- Product code
- NTE
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 5 generations to K003992 (2001). 8 ancestors in all. 4 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 · 5 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 4 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 3 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 2 generations backK051984 Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models…Boston Scientific Corp · 2006
- 1 generation backK061332 Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Boston Scientific Corp · 2006
- This deviceK063313 Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp · 2006
- Descendant · cites it directly · 3 of its ownK143570 WirionGardia Medical · 2015
- Descendant · 2 generations on · 2 of its ownK180023 WirionGardia Medical, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK200198 WirionCardiovascular Systems, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK210282 WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · Recalled (Class I)
Class I recalls in this family
- K210282 WIRION Embolic Protection System4 generations on · 2021
Most influential descendants
Showing 4 of 4 · See all- K143570WirionGardia Medical · 2015 · cites it directly3descendants
- K180023WirionGardia Medical, Ltd. · 2018 · 2 generations on2descendants
- K200198WirionCardiovascular Systems, Inc. · 2020 · 3 generations on1descendant
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −4 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −3 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K063313 | Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM) | Boston Scientific Corp | 2006 | — |
| +1 | K143570 | Wirion | Gardia Medical | 2015 | — |
| +2 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| +3 | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
| +4 | 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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
Top candidate predicates for a new NTE device
- #1 K222694 EmPro EPS (EP4514C-190…score 6.5 · 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? (3)
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…Ernbolic Protection System (FilterWire EZ System) is substantially equivalent in design and intended use (embolic protection) to the same devices legally marketed uinder K032884 (3.5 mm to 5.5 mm) and K06 1332 (2.25 mm to 3.5 mm) for use in saphenous vein bypass grafts. The FilterWire EZ System is also sub… | 2004 |
| * | K061332 | Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Summary page 1…terWire EZ System) is substantially equivalent in design and intended use (embolic protection) to the same devices legally marketed uinder K032884 (3.5 mm to 5.5 mm) and K06 1332 (2.25 mm to 3.5 mm) for use in saphenous vein bypass grafts. The FilterWire EZ System is also substantially equivalent in design… | 2006 |
| * | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection SystemSummary page 1…saphenous vein bypass grafts. The FilterWire EZ System is also substantially equivalent in design and indications for use to the RX ACCUNET"' Emnbolic Protection System (K0422 18) legally marketed as an embolic protection device for use in the carotid vasculature. Device Description: The Boston Scientific… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143570 | Wirion | 2015 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2008 | Not classified | Z-0105-2009 | Employee error | Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be… |
| May 20, 2008 | Not classified | Z-0108-2009 | Employee error | Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be… |
| May 20, 2008 | Not classified | Z-0110-2009 | Employee error | Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be… |
| May 20, 2008 | Not classified | Z-0106-2009 | Employee error | Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be… |
| May 20, 2008 | Not classified | Z-0107-2009 | Employee error | Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be… |
| May 20, 2008 | Not classified | Z-0109-2009 | Employee error | Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be… |
The 5 latest of 6 recalls; the web page lists all.
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 · 4 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 1.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K143570 (Gardia Medical, 2015) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K032884.
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.
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 FilterWire EZTM 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 and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm…
Read the full statement (112 words)
The FilterWire EZTM 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 and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral vasculature, peripheral vessels other than carotid arteries, or in treating native coronaries, including acute myocardial infarction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063313 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063313: Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063313
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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