510(k) Report

510(k) · Cleared

Cleared

Spiderfx Embolic Protection Device

K063785510(k) SpecialCleared Jan 19, 200729-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ev3, Inc. · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

Cleared on Jan 19, 2007 as substantially equivalent to K062201 (Ev3, Inc., 2006) after a 29-day review. Its family tree reaches back 5 generations to 2001. 1 of the 20 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.

Decided
Jan 19, 2007
Review
29 days
Class
Class II
Product code
NFA
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K003992 (2001). 7 ancestors in all. 12 later devices descend from it, 2 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2008: 1 descendant cleared2010: 1 descendant cleared2011: 2 descendants cleared2018: 2 descendants cleared2012: 2 descendants cleared2013: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared, 1 with a Class I recall1K003992 · Percusurge Guardwire Temporary Occlusion and Aspiration System · Percu Surge, Inc. · 2001K023691 · Boston Scientific Filterwire EX Embolic · Boston Scientific Epi · 2003K032884 · Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath · Boston Scientific Epi · 2004×2: 2 generations cleared close together, K053195 (2006), K062201 (2006) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants, 1 with a Class I recall1 K062201 · Spiderx Embolic Protection Device · Ev3, Inc. · 2006K053195 · Spiderx Embolic Protection Device · Ev3, Inc. · 2006K032884 · Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath · Boston Scientific Epi · 2004K023691 · Boston Scientific Filterwire EX Embolic · Boston Scientific Epi · 2003K003992 · Percusurge Guardwire Temporary Occlusion and Aspiration System · Percu Surge, Inc. · 2001−50+5
  1. Root · 5 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
  2. 4 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
  3. 3 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
  4. 2 generations backK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
  5. 1 generation backK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
  6. This deviceK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
  7. Descendant · cites it directly · 10 of its ownK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
  8. Descendant · 2 generations on · 5 of its ownK111750 Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta…Angioslide, Ltd. · 2011
  9. Descendant · 2 generations on · 4 of its ownK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
  10. Descendant · 3 generations on · 3 of its ownK120805 Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012
  11. Descendant · 3 generations on · 2 of its ownK180023 WirionGardia Medical, Ltd. · 2018

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12011: 22012: 22013: 12017: 12018: 22020: 12021: 1
2008high 2 (2011) · low 0 (2009)2026

Class I recalls in this family

  • K210282 WIRION Embolic Protection System5 generations on · 2021

Most influential descendants

Showing 5 of 12 · See all
  • K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010 · cites it directly10descendants
  • K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Angioslide, Ltd. · 2011 · 2 generations on5descendants
  • K111010Spiderfx Embolic Protection DeviceEv3, Inc. · 2011 · 2 generations on4descendants
  • K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012 · 3 generations on3descendants
  • K180023WirionGardia Medical, Ltd. · 2018 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K003992Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc.2001—
−4K023691Boston Scientific Filterwire EX EmbolicBoston Scientific Epi2003—
−3K032884Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathBoston Scientific Epi2004—
−2K053195Spiderx Embolic Protection DeviceEv3, Inc.2006—
−1K062201Spiderx Embolic Protection DeviceEv3, Inc.2006—
0 (this device)K063785Spiderfx Embolic Protection DeviceEv3, Inc.2007—
+1K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd.2010—
+2K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon…Angioslide, Ltd.2011—
+2K111010Spiderfx Embolic Protection DeviceEv3, Inc.2011—
+3K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.2012—
+3K180023WirionGardia Medical, Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201120
201220
201310
201710
201820
202010
202111
FIG. 1 — Lineage of K063785, 2001–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K062201Spiderx Embolic Protection Device
Summary page 1
…Catheter, Percutaneous Class: Class 11, 21 CFR 870.1250 Predicate Device: SpideRXTm Embolic Protection Device (K062201) Device Description: The SpiderFXTm Embolic Protection Device is a percutaneously delivered distal embolic protect…
Ev3, Inc.2006—

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd.201010
K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc.20080

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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K090364 (Angioslide, Ltd., 2010) has gone furthest, with 10 descendants of its own.

How does its category compare?

All NFA devices

NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NFA

2in 2008

2007: 12008: 2
2007high 2 (2008) · low 0 (2009)2026

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

2007: 1102008: 802009: 1042010: 1832011: 452012: 552013: 482014: 422015: 412016: 632017: 502018: 782019: 402020: 202021: 252022: 232023: 222024: 552025: 91
2007high 183 (2010) · low 20 (2020)2025

MAUDE reports naming product code NFA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0110
20082—080
20090—0104
20100—0183
20110—045
20120—055
20130—048
20140—042
20150—041
20160—063
20170—050
20180—078
20190—040
20200—020
20210—025
20220—023
20230—022
20240—055
20250—091
20260—0—

What is it indicated for?

The SpiderFXTM 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.

More from Ev3, Inc.

35 FDA decisions under this applicant name. See the company

  • K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 20141 recall
  • K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
  • K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
  • K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
  • K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 20111 recall

Recent decisions in NFA

The NFA category page

  • K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc. · 2008
  • K073563Modification to Proxis SystemSt Jude Medical · 2008
  • K062870Triactiv FX Embolic Protection System, Model PN 60040-02; -03Kensey Nash Corp. · 2006
  • K060651Proxis System, Model EPS101St Jude Medical · 2006
  • K052523Proxis SystemVelocimed, Inc. · 2006

https://510kreport.com/device/K063785 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063785: Spiderfx Embolic Protection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063785

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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