510(k) · Cleared
ClearedSpiderfx Embolic Protection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Nov 14, 2006 as substantially equivalent to K052659 (Ev3, Inc., 2006) after a 22-day review. Its family tree reaches back 4 generations to 2001. 1 of the 15 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Nov 14, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003992 (2001). 6 ancestors in all. 8 later devices descend from it, 3 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 3 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 2 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 1 generation backK052659 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- This deviceK063204 Spiderfx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
- 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 · cites it directly · 1 of its ownK103500 Gore Embolic FilterW. L. Gore & Associates, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK222694 EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS…MicroVention, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K210282 WIRION Embolic Protection System4 generations on · 2021
Most influential descendants
Showing 5 of 8 · See all- K111010Spiderfx Embolic Protection DeviceEv3, Inc. · 2011 · cites it directly4descendants
- K180023WirionGardia Medical, Ltd. · 2018 · 2 generations on2descendants
- K200198WirionCardiovascular Systems, Inc. · 2020 · 3 generations on1descendant
- K103500Gore Embolic FilterW. L. Gore & Associates, Inc. · 2011 · cites it directly1descendant
- K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −3 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K063204 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +1 | K111010 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2011 | — |
| +2 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| +3 | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
| +1 | K103500 | Gore Embolic Filter | W. L. Gore & Associates, Inc. | 2011 | — |
| +1 | K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | MicroVention, Inc. | 2023 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 1 |
| 2023 | 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.
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 6.4 · 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? (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 |
|---|---|---|---|
| * | K052659 | Spiderx Embolic Protection DeviceSummary page 1…Catheter, Percutaneous Class: Class 11, 21 CFR 870.1250 Predicate Devices: SpideRXTm Embolic Protection Device (K052659) Device Description: The SpiderFX Tm Embolic Protection Device is a percutaneously delivered distal embolic protect… | 2006 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- 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 1.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K111010 (Ev3, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K052659.
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 SpiderFXTM Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063204 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063204: Spiderfx Embolic Protection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063204
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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