510(k) · Cleared
ClearedGuardwire Temporary Occlusion and Aspiration System- Carotid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Oct 31, 2007 as substantially equivalent to K023878 (Medtronic Vascular, 2003) and 5 other predicates after a 7-day review. Its family tree reaches back 4 generations to 2001. 2 of the 26 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Oct 31, 2007
- Review
- 7 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K003992 (2001). 17 ancestors in all. 8 later devices descend from it, 2 citing it directly. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 3 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 2 generations backK042218 Accunet Embolic Protection System, RX Accunet Embolic Protection…Guidant Corp. · 2004
- 1 generation backK052166 Modification to: RX Accunet Embolic Protection SystemGuidant Corporation · 2005
- This deviceK072990 Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK143072 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK153485 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK082348 Fibernet Embolic Protection SystemLumen Biomedical, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 0 of its ownK230402 ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · cites it directly5descendants
- K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015 · 2 generations on2descendants
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 3 generations on1descendant
- K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc. · 2008 · cites it directly1descendant
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −3 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −2 | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection System | Guidant Corp. | 2004 | — |
| −1 | K052166 | Modification to: RX Accunet Embolic Protection System | Guidant Corporation | 2005 | — |
| 0 (this device) | K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | Medtronic, Inc. | 2007 | — |
| +1 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +2 | K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015 | — |
| +3 | K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016 | Class I |
| +1 | K082348 | Fibernet Embolic Protection System | Lumen Biomedical, Inc. | 2008 | 2 |
| +4 | K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023 | Class I |
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 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 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? (6)
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 |
|---|---|---|---|
| * | K023878 | Guardwire Temporary Occlusion and Aspiration SystemSummary page 1…GuardWire® Temporary Occlusion and Aspiration System 4. Name of Predicate Devices: GuardWire® 3-6 Temporary Occlusion and Aspiration System K023878 6F Export® Catheter K030201 Export® XT Catheter… | 2003 |
| * | K030201 | Modification to Export Aspiration CatheterSummary page 1…evices: GuardWire® 3-6 Temporary Occlusion and Aspiration System K023878 6F Export® Catheter K030201 Export® XT Catheter K061958 RX ACCUNETTM Embolic Protection System… | 2003 |
| * | K061958 | Medtronic Export XT CatheterSummary page 1…K023878 6F Export® Catheter K030201 Export® XT Catheter K061958 RX ACCUNETTM Embolic Protection System K052166 SpideRX® Embolic Protection Device… | 2006 |
| * | K052166 | Modification to: RX Accunet Embolic Protection SystemSummary page 1…K030201 Export® XT Catheter K061958 RX ACCUNETTM Embolic Protection System K052166 SpideRX® Embolic Protection Device K052659 The Emboshield® Embolic Protection Sys… | 2005 |
| * | K052659 | Spiderx Embolic Protection DeviceSummary page 1…K061958 RX ACCUNETTM Embolic Protection System K052166 SpideRX® Embolic Protection Device K052659 The Emboshield® Embolic Protection System K052454 5. Description: The GuardWire® Tem… | 2006 |
| * | K052454 | The Emboshield Embolic Protection SystemSummary page 1…K052166 SpideRX® Embolic Protection Device K052659 The Emboshield® Embolic Protection System K052454 5. Description: The GuardWire® Temporary Occlusion and Aspiration System is comprised of four principal components… | 2005 |
What descends from it? (8)
2 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 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K083300 (W. L. Gore & Associates, Inc., 2009) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K023878.
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. 2007, 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 GuardWire Temporary Occlusion and Aspiration System is indicated for use in carotid arteries to:
Contain and aspirate embolic material (thrombus/debris) while performing angioplasty or stenting procedures.
Facilitate placement and use of diagnostic or therapeutic catheters using the GuardWire Temporary Occlusion Catheter.
To locally infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
The diameter of the artery where the occlusion balloon is placed should be between 3 and 6 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072990 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072990: Guardwire Temporary Occlusion and Aspiration System- Carotid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072990
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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