510(k) · Cleared
ClearedSpiderx Embolic Protection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cleared on Jun 23, 2006 as substantially equivalent to K032884 (Boston Scientific Epi, 2004) and 1 other predicate after a 220-day review. Its family tree reaches back 3 generations to 2001. 1 of the 20 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 220 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003992 (2001). 5 ancestors in all. 14 later devices descend from it, 1 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 2 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 1 generation backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- This deviceK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · cites it directly · 13 of its ownK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · 2 generations on · 12 of its ownK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- Descendant · 3 generations on · 10 of its ownK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- Descendant · 4 generations on · 5 of its ownK111750 Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta…Angioslide, Ltd. · 2011
- Descendant · 4 generations on · 4 of its ownK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K210282 WIRION Embolic Protection System7 generations on · 2021
Most influential descendants
Showing 5 of 14 · See all- K062201Spiderx Embolic Protection DeviceEv3, Inc. · 2006 · cites it directly13descendants
- K063785Spiderfx Embolic Protection DeviceEv3, Inc. · 2007 · 2 generations on12descendants
- K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010 · 3 generations on10descendants
- K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Angioslide, Ltd. · 2011 · 4 generations on5descendants
- K111010Spiderfx Embolic Protection DeviceEv3, Inc. · 2011 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +1 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +2 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| +3 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
| +4 | K111750 | Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon… | Angioslide, Ltd. | 2011 | — |
| +4 | K111010 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 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.
- 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 |
|---|---|---|---|
| * | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathSummary page 1…Catheter, Percutaneous Class: Class 11, 21 CFR 870.1250 Predicate Devices: FilterWire EZTM Embolic Protection System (K032884) GuardWire®Plus Temporary Occlusion and Aspiration System (K023878) Device Description: The SpideRXTM Embolic Prote… | 2004 |
| * | K023878 | Guardwire Temporary Occlusion and Aspiration SystemSummary page 1…Class 11, 21 CFR 870.1250 Predicate Devices: FilterWire EZTM Embolic Protection System (K032884) GuardWire®Plus Temporary Occlusion and Aspiration System (K023878) Device Description: The SpideRXTM Embolic Protection Device is a percutaneously delivered distal embolic protecti… | 2003 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062201 | Spiderx Embolic Protection Device | 2006 | 13 |
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 · 7 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 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K062201 (Ev3, Inc., 2006) has gone furthest, with 13 descendants of its own.
- 6 other devices also cite its predicate K032884.
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 SpideRX Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053195: Spiderx 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/K053195
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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