510(k) · Cleared
ClearedBoston Scientific Filterwire EX Embolic
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 Jun 4, 2003 as substantially equivalent to K003992 (Percu Surge, Inc., 2001) and 1 other predicate after a 215-day review. Its family tree reaches back 1 generation to 2001. 3 of the 51 devices in its family, counting itself, have a Class I recall. 48 later devices descend from it.
- Decided
- Jun 4, 2003
- Review
- 215 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003992 (2001). 2 ancestors in all. 48 later devices descend from it, 4 citing it directly. 3 of the 51 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- This deviceK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- Descendant · cites it directly · 35 of its ownK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- Descendant · cites it directly · 27 of its ownK042218 Accunet Embolic Protection System, RX Accunet Embolic Protection…Guidant Corp. · 2004
- Descendant · 2 generations on · 18 of its ownK052659 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · 2 generations on · 14 of its ownK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · 3 generations on · 13 of its ownK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 48 · See all- K032884Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathBoston Scientific Epi · 2004 · cites it directly35descendants
- K042218Accunet Embolic Protection System, RX Accunet Embolic Protection SystemGuidant Corp. · 2004 · cites it directly27descendants
- K052659Spiderx Embolic Protection DeviceEv3, Inc. · 2006 · 2 generations on18descendants
- K053195Spiderx Embolic Protection DeviceEv3, Inc. · 2006 · 2 generations on14descendants
- K062201Spiderx Embolic Protection DeviceEv3, Inc. · 2006 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| 0 (this device) | 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 | — |
| +1 | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection System | Guidant Corp. | 2004 | — |
| +2 | K052659 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +2 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +3 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 9 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration SystemSummary page 1…MedtronicB AVE PercuSurge Guardwire Plus@ Temporary Occlusion and Aspiration System (K003992, KO14223) Device Description The Boston Scientific Filterwire EXTMEmbolic Protection System is a temporary intra-vascular 0.… | 2001 |
| * | K014223 | Modification to Guardwire Plus Temporary Occlusion & Aspiration System | 2002 |
What descends from it? (48)
See all 484 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 EX 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/K023691 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023691: Boston Scientific Filterwire EX Embolic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023691
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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