510(k) · Cleared
ClearedGore Flow Reversal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Feb 4, 2009 as substantially equivalent to K021210 (Arteria Medical Science, Inc., 2002) and 3 other predicates after an 86-day review. Its family tree reaches back 5 generations to 2001. 2 of the 33 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Feb 4, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K003992 (2001). 27 ancestors in all, the oldest K990487 (1999). 5 later devices descend from it, 3 citing it directly. 2 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 4 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 3 generations backK042218 Accunet Embolic Protection System, RX Accunet Embolic Protection…Guidant Corp. · 2004
- 2 generations backK052166 Modification to: RX Accunet Embolic Protection SystemGuidant Corporation · 2005
- 1 generation backK072990 Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007
- This deviceK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK143072 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK153485 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK230402 ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK123156 Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK092177 MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A. · 2009 · Recalled
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015 · cites it directly2descendants
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 2 generations on1descendant
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 3 generations on0descendants
- K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc. · 2012 · cites it directly0descendants
- K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −4 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −3 | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection System | Guidant Corp. | 2004 | — |
| −2 | K052166 | Modification to: RX Accunet Embolic Protection System | Guidant Corporation | 2005 | — |
| −1 | K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | Medtronic, Inc. | 2007 | — |
| 0 (this device) | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +1 | K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015 | — |
| +2 | K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016 | Class I |
| +3 | K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023 | Class I |
| +1 | K123156 | Gore Flow Reversal System Model GFRS073 | W. L. Gore & Associates, Inc. | 2012 | — |
| +1 | K092177 | MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6 | Invatec S.P.A. | 2009 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2023 | 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.
2 devices in this family have 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? (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 |
|---|---|---|---|
| * | K021210 | Arteria Occlusion BalloonSummary page 1…atheter, carotid, temporary, for embolization capture * Classification -21CFR 870.1250, NTE ClasslII 3. Device Predicates [807.92(a)(3)] K02121 0 Arteria Occlusion Balloon K021293 Arteria Blood Filter K070770 GORE Balloon Sheath K072990… | 2002 |
| * | K021293 | Arteria Blood FilterSummary page 1…pture * Classification -21CFR 870.1250, NTE ClasslII 3. Device Predicates [807.92(a)(3)] K02121 0 Arteria Occlusion Balloon K021293 Arteria Blood Filter K070770 GORE Balloon Sheath K072990 Guardwire Temporary Occlusion and Aspiration S… | 2002 |
| * | K070770 | Gore Balloon SheathSummary page 1…R 870.1250, NTE ClasslII 3. Device Predicates [807.92(a)(3)] K02121 0 Arteria Occlusion Balloon K021293 Arteria Blood Filter K070770 GORE Balloon Sheath K072990 Guardwire Temporary Occlusion and Aspiration System 4. Description of the Device [… | 2007 |
| * | K072990 | Guardwire Temporary Occlusion and Aspiration System- CarotidSummary page 1…Predicates [807.92(a)(3)] K02121 0 Arteria Occlusion Balloon K021293 Arteria Blood Filter K070770 GORE Balloon Sheath K072990 Guardwire Temporary Occlusion and Aspiration System 4. Description of the Device [807.92(a)(4)] The GORE Flow… | 2007 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K143072 (Silk Road Medical, Inc., 2015) has gone furthest, with 2 descendants of its own.
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. 2009, 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 GORE Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:
Adequate iliac/femoral access
Common carotid artery diameters between 6 and 12 mm
External carotid artery diameters less than 6 mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083300: Gore Flow Reversal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083300
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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