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 · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on May 4, 2012 as substantially equivalent to K081523 (Abbott Vascular-Vascular Solutions, 2008) and 2 other predicates after a 30-day review. Its family tree reaches back 4 generations to 2004. 2 later devices descend from it.
- Decided
- May 4, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K042908 (2004). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK042908 RX Accunet 2 Embolic Protection SystemGuidant Corp. · 2004
- 3 generations backK052454 The Emboshield Embolic Protection SystemAbbott Vascular Devices · 2005
- 2 generations backK081523 Emboshield NAV6 Embolic Protection SystemAbbott Vascular-Vascular Solutions · 2008
- 1 generation backK110909 Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery…Abbott Laboratories · 2011
- This deviceK121015 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042908 | RX Accunet 2 Embolic Protection System | Guidant Corp. | 2004 | — |
| −3 | K052454 | The Emboshield Embolic Protection System | Abbott Vascular Devices | 2005 | — |
| −2 | K081523 | Emboshield NAV6 Embolic Protection System | Abbott Vascular-Vascular Solutions | 2008 | — |
| −1 | K110909 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery… | Abbott Laboratories | 2011 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K081523 | Emboshield NAV6 Embolic Protection System Our reading of the summary gave K051523, FDA’s number for Regius Console CS-2000 and Regius Console CS-3000, Medical… (Konica Minolta Medical & Graphic, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Emboshield NAV 6 Embolic Protection System”. | 2008 |
| * | K090665 | Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19Summary page 1…(KOSI1523) * Emboshield NAy 6 Embolic Protection System (K090665) * Emboshield NAV 6 Embolic Protection System (KI… | 2009 |
| * | K110909 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wire-Workhorse-190CM…Summary page 3…o change the adhesive used to attach the radiopaque marker onto the delivery catheter component of the NAV system. No other changes were made to the device cleared under K 110909. Therefore, the technological characteristics such as product performance, design and intended use are substantially equivalent t… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141678 | Emboshield NAV6 Embolic Protection System | 2014 | 1 |
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 8 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K141678 (Abbott Vascular, 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K081523.
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. 2012, 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 guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121015 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121015: Emboshield NAV6 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/K121015
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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