510(k) · Cleared
ClearedAngioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Jul 9, 2010 as substantially equivalent to K062531 (Cordis Corp., A Johnson & Johnson Co., 2006) after a 28-day review. Its family tree reaches back 1 generation to 2006. 2 of the 7 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Jul 9, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062531 (2006). 5 later devices descend from it, 2 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK062531 Angioguard XP Emboli Capture Guidewire and Angioguard RX Emboli…Cordis Corp., A Johnson & Johnson Co. · 2006
- This deviceK101651 Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture…Cordis Corp. · 2010
- Descendant · cites it directly · 3 of its ownK143570 WirionGardia Medical · 2015
- Descendant · 2 generations on · 2 of its ownK180023 WirionGardia Medical, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK200198 WirionCardiovascular Systems, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK220654 ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture…Cordis Corporation · 2022 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK210282 WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K143570WirionGardia Medical · 2015 · cites it directly3descendants
- K180023WirionGardia Medical, Ltd. · 2018 · 2 generations on2descendants
- K200198WirionCardiovascular Systems, Inc. · 2020 · 3 generations on1descendant
- K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation · 2022 · cites it directly0descendants
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062531 | Angioguard XP Emboli Capture Guidewire and Angioguard RX Emboli Capture… | Cordis Corp., A Johnson & Johnson Co. | 2006 | — |
| 0 (this device) | K101651 | Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture Guidewire | Cordis Corp. | 2010 | — |
| +1 | K143570 | Wirion | Gardia Medical | 2015 | — |
| +2 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
| +3 | K200198 | Wirion | Cardiovascular Systems, Inc. | 2020 | — |
| +1 | K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | Cordis Corporation | 2022 | Class I |
| +4 | K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | 2021 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 1 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K062531 | Angioguard XP Emboli Capture Guidewire and Angioguard RX Emboli Capture Guidewire Our reading of the summary gave “K062531” beside “510(k)”; FDA’s K062531 is the only number that fits it and was decided on the date printed beside it. Summary page 1…n System (K023691) and PercuSurge, Inc.'s Percusurge Guardwire Temporary Occlusion and Aspiration System (K013913) via 510(k) K062531 on September 22, 2006.… | 2006 |
| * | — | ANGIOGUARD RX Emboli Capture Guidewire Named without a submission number |
What descends from it? (5)
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.
- K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation · 2022 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 114 Class I recalls
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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. 2010, 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 ANGIOGUARD TMXP Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm. The ANGIOGUARD TM RX Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection…
Read the full statement (109 words)
The ANGIOGUARD TMXP Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.
The ANGIOGUARD TM RX Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101651: Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101651
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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