510(k) · Cleared
ClearedEmboshield NAV6 Embolic Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular-Vascular Solutions · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Sep 11, 2008 as substantially equivalent to K052454 (Abbott Vascular Devices, 2005) after a 101-day review. Its family tree reaches back 2 generations to 2004. 4 later devices descend from it.
- Decided
- Sep 11, 2008
- Review
- 101 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042908 (2004). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK042908 RX Accunet 2 Embolic Protection SystemGuidant Corp. · 2004
- 1 generation backK052454 The Emboshield Embolic Protection SystemAbbott Vascular Devices · 2005
- This deviceK081523 Emboshield NAV6 Embolic Protection SystemAbbott Vascular-Vascular Solutions · 2008
- Descendant · cites it directly · 3 of its ownK110909 Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery…Abbott Laboratories · 2011
- Descendant · cites it directly · 2 of its ownK121015 Emboshield NAV6 Embolic Protection SystemAbbott Vascular · 2012
- Descendant · cites it directly · 1 of its ownK141678 Emboshield NAV6 Embolic Protection SystemAbbott Vascular · 2014
- Descendant · 2 generations on · 0 of its ownK191173 Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery…Abbott Vascular · 2019
Most influential descendants
Showing 4 of 4 · See all- K110909Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wire-Workhorse-190CM…Abbott Laboratories · 2011 · cites it directly3descendants
- K121015Emboshield NAV6 Embolic Protection SystemAbbott Vascular · 2012 · cites it directly2descendants
- K141678Emboshield NAV6 Embolic Protection SystemAbbott Vascular · 2014 · cites it directly1descendant
- K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042908 | RX Accunet 2 Embolic Protection System | Guidant Corp. | 2004 | — |
| −1 | K052454 | The Emboshield Embolic Protection System | Abbott Vascular Devices | 2005 | — |
| 0 (this device) | K081523 | Emboshield NAV6 Embolic Protection System | Abbott Vascular-Vascular Solutions | 2008 | — |
| +1 | K110909 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery… | Abbott Laboratories | 2011 | — |
| +1 | K121015 | Emboshield NAV6 Embolic Protection System | Abbott Vascular | 2012 | — |
| +1 | K141678 | Emboshield NAV6 Embolic Protection System | Abbott Vascular | 2014 | — |
| +2 | K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | Abbott Vascular | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052454 | The Emboshield Embolic Protection SystemSummary page 1…ification Name: catheter, carotid, temporary, for embolization capture Product Code: NTE Predicate Device: Emboshield® Embolic Protection System (K052454) Intended Use: The Emboshield Embolic Protection System is indicated for use as a guidewire… | 2005 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K110909 (Abbott Laboratories, 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K052454.
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 Emboshield NAV 6 Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in the carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 mm and 7.0 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081523: Emboshield NAV6 Embolic Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081523
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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