# K202835: Auryon Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Eximo Medical, Ltd.
- Decided: Dec 2, 2020 after 68 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: 15 generations back to K890505 (1989). 41 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181642: B-Laser Atherectomy System, Eximo Medical, Ltd. (2018) Summary page 4.

## Most influential descendants
- K220116: Auryon Atherectomy Catheters (2022), 4 descendants of its own
- 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 is intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).

Source page: https://510kreport.com/device/K202835
Methodology: https://510kreport.com/methodology