510(k) · Cleared
ClearedGore Embolic Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on May 23, 2011 as substantially equivalent to K063204 (Ev3, Inc., 2006) and 1 other predicate after a 175-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- May 23, 2011
- Review
- 175 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003992 (2001). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK052659 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 1 generation backK063204 Spiderfx Embolic Protection DeviceEv3, Inc. · 2006
- This deviceK103500 Gore Embolic FilterW. L. Gore & Associates, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK120480 Gore (R) Embolic FilterW.L. Gore & Associates · 2012
Most influential descendants
Showing 1 of 1 · See all- K120480Gore (R) Embolic FilterW.L. Gore & Associates · 2012 · cites it directly0descendants
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 | K052659 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −1 | K063204 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| 0 (this device) | K103500 | Gore Embolic Filter | W. L. Gore & Associates, Inc. | 2011 | — |
| +1 | K120480 | Gore (R) Embolic Filter | W.L. Gore & Associates | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 NTE? 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 6.4 · 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? (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 |
|---|---|---|---|
| * | K063204 | Spiderfx Embolic Protection DeviceSummary page 1…assification name - Temporary carotid catheter for embolic capture " Classification - 21CFR 870.1250, NTE Class 11 3. Device Predicates [807.92(a)(3)] K063204 SpiderFX Embolic Protection Device, ev3 K042218 Accunet Embolic Protection System, Abbott 4. Description of the Device [… | 2006 |
| * | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection SystemSummary page 1…c capture " Classification - 21CFR 870.1250, NTE Class 11 3. Device Predicates [807.92(a)(3)] K063204 SpiderFX Embolic Protection Device, ev3 K042218 Accunet Embolic Protection System, Abbott 4. Description of the Device [807.92(a)(4)] The GORE® Embolic Filter system con… | 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 |
|---|---|---|---|
| K120480 | Gore (R) Embolic Filter | 2012 | 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 10 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K120480 (W.L. Gore & Associates, 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063204.
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. 2011, this device’s year, is highlighted.
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 GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103500 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103500: Gore Embolic Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103500
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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