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 Oct 27, 2011 as substantially equivalent to K063204 (Ev3, Inc., 2006) and 2 other predicates after a 199-day review. Its family tree reaches back 7 generations to 2001. 1 of the 19 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Oct 27, 2011
- Review
- 199 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K003992 (2001). 14 ancestors in all. 4 later devices descend from it, 2 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 6 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 5 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 4 generations backK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 3 generations backK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 2 generations backK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- 1 generation backK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- This deviceK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK180023 WirionGardia Medical, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK200198 WirionCardiovascular Systems, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK210282 WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK181529 Vanguard IEP Peripheral Balloon Angioplasty System with Integrated…Contego Medical, LLC · 2018
Class I recalls in this family
- K210282 WIRION Embolic Protection System3 generations on · 2021
Most influential descendants
Showing 4 of 4 · See all- K180023WirionGardia Medical, Ltd. · 2018 · cites it directly2descendants
- K200198WirionCardiovascular Systems, Inc. · 2020 · 2 generations on1descendant
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 3 generations on0descendants
- K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −6 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −5 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −4 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −3 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −2 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| −1 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
| 0 (this device) | K111010 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2011 | — |
| +1 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| +2 | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
| +3 | K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | 2021 | Class I |
| +1 | K181529 | Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic… | Contego Medical, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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 6.4 · 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? (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 |
|---|---|---|---|
| * | K063204 | Spiderfx Embolic Protection DeviceSummary page 1…Protection Device Angioslide eXtra TM PTA Balloon Catheter with Embolic Capture Feature 51 0(k) Number K063204; K052659; K090364 5 10(k) Clearance Date November 14, 2006; February 17, 2006; March 23, 20 10 4. Device Description The Sp… | 2006 |
| * | K052659 | Spiderx Embolic Protection DeviceSummary page 1…on Device Angioslide eXtra TM PTA Balloon Catheter with Embolic Capture Feature 51 0(k) Number K063204; K052659; K090364 5 10(k) Clearance Date November 14, 2006; February 17, 2006; March 23, 20 10 4. Device Description The SpiderFXO E… | 2006 |
| * | K090364 | Extra Pta Balloon Catheter with Embolic Protection FeatureSummary page 1…Angioslide eXtra TM PTA Balloon Catheter with Embolic Capture Feature 51 0(k) Number K063204; K052659; K090364 5 10(k) Clearance Date November 14, 2006; February 17, 2006; March 23, 20 10 4. Device Description The SpiderFXO Embolic Pr… | 2010 |
What descends from it? (4)
2 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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 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 1.6 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K180023 (Gardia Medical, Ltd., 2018) has gone furthest, with 2 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 SpiderFX®0 Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material in conjunction with the TurboHawk, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111010: Spiderfx Embolic Protection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111010
Report an extraction error
Are you the manufacturer?
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