510(k) Report

510(k) · Cleared

Cleared

Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19

K090665510(k) SpecialCleared May 22, 200970-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Vascular-Vascular Solutions · NTE Temporary Carotid Catheter For Embolic Capture

Cleared on May 22, 2009 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
May 22, 2009
Review
70 days
Class
Class II
Product code
NTE
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2019: 1 descendant cleared20052010201520202025
  1. This deviceK090665 Emboshield NAV6 Embolic Protection System-Small/Large, Model…Abbott Vascular-Vascular Solutions · 2009
  2. Descendant · cites it directly · 3 of its ownK110909 Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery…Abbott Laboratories · 2011
  3. Descendant · cites it directly · 2 of its ownK121015 Emboshield NAV6 Embolic Protection SystemAbbott Vascular · 2012
  4. Descendant · cites it directly · 1 of its ownK141678 Emboshield NAV6 Embolic Protection SystemAbbott Vascular · 2014
  5. 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K090665Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19Abbott Vascular-Vascular Solutions2009—
+1K110909Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery…Abbott Laboratories2011—
+1K121015Emboshield NAV6 Embolic Protection SystemAbbott Vascular2012—
+1K141678Emboshield NAV6 Embolic Protection SystemAbbott Vascular2014—
+2K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201410
201910
FIG. 1 — Lineage of K090665, 2009–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K222694 EmPro EPS (EP4514C-190…score 6.4 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110909Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wire-Workhorse-190CM…Abbott Laboratories20113
K121015Emboshield NAV6 Embolic Protection SystemAbbott Vascular20122
K141678Emboshield NAV6 Embolic Protection SystemAbbott Vascular20141

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?

  • Of its descendants, K110909 (Abbott Laboratories, 2011) has gone furthest, with 3 descendants of its own.

How does its category compare?

All NTE devices

NTE 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

2007: 12008: 32009: 32010: 12011: 42012: 32014: 12015: 32016: 12018: 12019: 12020: 12021: 12022: 12023: 2
2007high 4 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NTE

105in 2015

2008: 95 days median2009: 86 days median2011: 105 days median2012: 30 days median2015: 105 days median
2007high 105 (2011) · low 30 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NTE

3in 2023

2008: 62011: 12021: 1, 1 Class I2023: 32026 (partial year): 2, 2 Class I
2007high 6 (2008) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · NTE

405in 2025

2007: 1192008: 3682009: 3432010: 2942011: 3042012: 2612013: 2582014: 1992015: 1482016: 1482017: 1412018: 1582019: 2332020: 2382021: 3272022: 3262023: 3542024: 3982025: 405
2007high 405 (2025) · low 119 (2007)2025

MAUDE reports naming product code NTE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0119
20083956368
20093860343
20101—0294
201141051304
20123300261
20130—0258
20141—0199
201531050148
20161—0148
20170—0141
20181—0158
20191—0233
20201—0238
20211—1 (1)327
20221—0326
20232—3354
20240—0398
20250—0405
20260—2 (2)—

More from Abbott Vascular-Vascular Solutions

6 FDA decisions under this applicant name. See the company

  • K090509Foxcross .035 Pta Catheter 14 MM X 20MM X 80 CM, Model 10342-20, Foxcross .035 Pta CatheterAbbott Vascular-Vascular Solutions · 2009
  • K081523Emboshield NAV6 Embolic Protection SystemAbbott Vascular-Vascular Solutions · 2008
  • K072708Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions · 2008
  • K080264Modification to: Fox Plus Pta CatheterAbbott Vascular-Vascular Solutions · 2008
  • K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 20081 recall

Recent decisions in NTE

The NTE category page

  • K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc. · 2023
  • K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 20231 Class I recall
  • K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation · 202214 Class I recalls
  • K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 20211 Class I recall
  • K200198WirionCardiovascular Systems, Inc. · 2020

https://510kreport.com/device/K090665 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090665: Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090665

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026