510(k) · Cleared
Recalled · Class II · 2014Fibernet Embolic Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumen Biomedical, Inc. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Nov 18, 2008 as substantially equivalent to K032884 (Boston Scientific Epi, 2004) and 3 other predicates after a 95-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Nov 18, 2008
- Review
- 95 days
- Class
- Class II
- Product code
- NTE
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 6 generations to K010579 (2001). 24 ancestors in all, the oldest K003992 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 5 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 4 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 3 generations backK050139 Modification to: Export CatheterMedtronic Vascular · 2005
- 2 generations backK053372 Lbi Catheter SystemLumen Biomedical, Inc. · 2006
- 1 generation backK071529 Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · Recalled
- This deviceK082348 Fibernet Embolic Protection SystemLumen Biomedical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK111987 Fibernet Embolic Protection DeviceLumen Biomedical, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −5 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −4 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −3 | K050139 | Modification to: Export Catheter | Medtronic Vascular | 2005 | — |
| −2 | K053372 | Lbi Catheter System | Lumen Biomedical, Inc. | 2006 | — |
| −1 | K071529 | Xtract Catheter System | Lumen Biomedical, Inc. | 2007 | 1 |
| 0 (this device) | K082348 | Fibernet Embolic Protection System | Lumen Biomedical, Inc. | 2008 | — |
| +1 | K111987 | Fibernet Embolic Protection Device | Lumen Biomedical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (4)
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…de Name: FiberNet® Embolic Protection System Common Name: Embolic Protection Device Classification Name: Catheter, Percutaneous Predicate(s): K032884 FilterWire EZTM Embolic Protection System K052659 SpideRXTM Embolic Protection System… | 2004 |
| * | K052659 | Spiderx Embolic Protection DeviceSummary page 1…mbolic Protection Device Classification Name: Catheter, Percutaneous Predicate(s): K032884 FilterWire EZTM Embolic Protection System K052659 SpideRXTM Embolic Protection System K072990 Guardwire System K071529 XtractTM Asp… | 2006 |
| * | K072990 | Guardwire Temporary Occlusion and Aspiration System- CarotidSummary page 1…ous Predicate(s): K032884 FilterWire EZTM Embolic Protection System K052659 SpideRXTM Embolic Protection System K072990 Guardwire System K071529 XtractTM Aspiration Catheter Intended Use: The FiberNet® Embolic Prote… | 2007 |
| * | K071529 | Xtract Catheter SystemSummary page 1…TM Embolic Protection System K052659 SpideRXTM Embolic Protection System K072990 Guardwire System K071529 XtractTM Aspiration Catheter Intended Use: The FiberNet® Embolic Protection System is indicated for use as a… | 2007 |
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 |
|---|---|---|---|
| K111987 | Fibernet Embolic Protection Device | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2014 | Class II | Z-1304-2014 | Manufacturing material removal | Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and… |
| Mar 3, 2014 | Class II | Z-1303-2014 | Manufacturing material removal | Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K111987 (Lumen Biomedical, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K032884.
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. 2008, 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 FiberNet ® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082348 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082348: Fibernet Embolic Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082348
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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