Atherectomy
Auryon Atherectomy Catheter
A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.
Auryon Atherectomy Catheter models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| EXM-4001-H000 | Outer Diameter 1.5 mm; Length 150 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4002-H000 | Outer Diameter 0.9 mm; Length 150 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4003-H000 | Outer Diameter 2 mm; Length 135 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4004-H000 | Outer Diameter 2.35 mm; Length 110 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4010-0000 | Outer Diameter 1.5 mm; Length 225 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4010-H000 | Outer Diameter 1.5 mm; Length 225 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4011-0000 | Outer Diameter 0.9 mm; Length 225 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4011-H000 | Outer Diameter 0.9 mm; Length 225 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4012-0000 | Outer Diameter 1.7 mm; Length 150 cm | Not stated | Available |
| EXM-4012-H000 | Outer Diameter 1.7 mm; Length 150 cm | Not stated | Available |
FDA clearances
- 510(k) K241553 June 2024
- 510(k) K233668 December 2023
- 510(k) K220116 September 2022
Procedures that use atherectomy
Frequently asked questions
What is Auryon Atherectomy Catheter used for?
A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.
Who makes Auryon Atherectomy Catheter?
Auryon Atherectomy Catheter is made by Eximo Medical Ltd. It is listed under atherectomy devices in our device library.
What sizes does Auryon Atherectomy Catheter come in?
Sizes listed for Auryon Atherectomy Catheter: Outer Diameter: 0.9–2.35 mm; Length: 110–225 cm; Lumen/Inner Diameter: 0.01 in. Confirm availability with the manufacturer's instructions for use.
Is Auryon Atherectomy Catheter MRI safe?
The FDA device database entry for Auryon Atherectomy Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Auryon Atherectomy Catheter FDA cleared?
Auryon Atherectomy Catheter is covered by FDA submissions K241553, K233668, K220116.
How do I contact a Eximo Medical Ltd sales representative?
Eximo Medical Ltd has not listed representatives on LA Vascular yet. Visit the Eximo Medical Ltd company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.