510(k) · Cleared
Recalled · Class I · 2023ANGIOGUARD 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 Corporation · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Apr 6, 2022 as substantially equivalent to K101651 (Cordis Corp., 2010) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 2006. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled 14 times, including 14 Class I recalls.
- Decided
- Apr 6, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- NTE
- Recalls
- 14 (14 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K062531 (2006). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK062531 Angioguard XP Emboli Capture Guidewire and Angioguard RX Emboli…Cordis Corp., A Johnson & Johnson Co. · 2006
- 1 generation backK101651 Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture…Cordis Corp. · 2010
- This deviceK220654 ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture…Cordis Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062531 | Angioguard XP Emboli Capture Guidewire and Angioguard RX Emboli Capture… | Cordis Corp., A Johnson & Johnson Co. | 2006 | — |
| −1 | K101651 | Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture Guidewire | Cordis Corp. | 2010 | — |
| 0 (this device) | K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | Cordis Corporation | 2022 | — |
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.
1 device in this family has 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 |
|---|---|---|---|
| * | K101651 | Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture GuidewireSummary page 4…tid catheter for embolic capture III. PREDICATE DEVICE ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire, previously cleared under K101651 on July 9, 2010, and under K062531 on September 22, 2006. IV. DEVICE DESCRIPTION Both the subject and predicate ANGIOGUARD… | 2010 |
| * | K062531 | Angioguard XP Emboli Capture Guidewire and Angioguard RX Emboli Capture GuidewireSummary page 4…III. PREDICATE DEVICE ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire, previously cleared under K101651 on July 9, 2010, and under K062531 on September 22, 2006. IV. DEVICE DESCRIPTION Both the subject and predicate ANGIOGUARD XP Emboli Capture Guidewire and… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2023 | Class I | Z-1487-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1492-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1484-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1493-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1486-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1496-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1489-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1485-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1490-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1494-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1488-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1483-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1495-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
| Mar 24, 2023 | Class I | Z-1491-2023 | Vendor change control | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke… |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K101651.
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. 2022, 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?
ANGIOGUARD XP and ANGIOGUARD RX Emboli Capture Guidewire devices are 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 7.5mm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220654: 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/K220654
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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