# K101651: Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture Guidewire

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Jul 9, 2010 after 28 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K062531 (2006). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062531: Angioguard XP Emboli Capture Guidewire and Angioguard RX Emboli Capture Guidewire, Cordis Corp., A Johnson & Johnson Co. (2006). 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.
- (no number) ANGIOGUARD RX Emboli Capture Guidewire: named in the summary without a submission number

## Most influential descendants
- K143570: Wirion (2015), 3 descendants of its own
- K180023: Wirion (2018), 2 descendants of its own
- K200198: Wirion (2020), 1 descendant of its own
- K220654: ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire (2022), 0 descendants of its own
- K210282: WIRION Embolic Protection System (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K101651
Methodology: https://510kreport.com/methodology