# K220116: Auryon Atherectomy Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Eximo Medical, Ltd.
- Decided: Sep 26, 2022 after 255 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K890505 (1989). 42 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202835: Auryon Atherectomy System, Eximo Medical, Ltd. (2020) Summary page 4.

## Most influential descendants
- K230709: Auryon Atherectomy System (2023), 3 descendants of its own
- K233668: Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) (2023), 2 descendants of its own
- K260244: Auryon Atherectomy System (2026), 0 descendants of its own
- K241553: Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating (2024), 0 descendants of its own

## Indications for use
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.

Source page: https://510kreport.com/device/K220116
Methodology: https://510kreport.com/methodology