# K220654: ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire

- Pathway: 510(k) (Special)
- Applicant: Cordis Corporation
- Decided: Apr 6, 2022 after 30 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 14 (14 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K062531 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101651: Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture Guidewire, Cordis Corp. (2010) Summary page 4.
- K062531: Angioguard XP Emboli Capture Guidewire and Angioguard RX Emboli Capture Guidewire, Cordis Corp., A Johnson & Johnson Co. (2006) Summary page 4.

## Recalls of this device
- Mar 24, 2023 · Class I · Z-1487-2023: 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
- Mar 24, 2023 · Class I · Z-1492-2023: 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
- Mar 24, 2023 · Class I · Z-1484-2023: 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
- Mar 24, 2023 · Class I · Z-1493-2023: 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
- Mar 24, 2023 · Class I · Z-1486-2023: 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
- Mar 24, 2023 · Class I · Z-1496-2023: 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
- Mar 24, 2023 · Class I · Z-1489-2023: 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
- Mar 24, 2023 · Class I · Z-1485-2023: 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
- Mar 24, 2023 · Class I · Z-1490-2023: 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
- Mar 24, 2023 · Class I · Z-1494-2023: 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
- Mar 24, 2023 · Class I · Z-1488-2023: 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
- Mar 24, 2023 · Class I · Z-1483-2023: 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
- Mar 24, 2023 · Class I · Z-1495-2023: 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
- Mar 24, 2023 · Class I · Z-1491-2023: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K220654
Methodology: https://510kreport.com/methodology