Atherectomy
Auryon Atherectomy Catheter 1.5 mm OTW
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 1.5 mm OTW 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-4001-0000 | Outer Diameter 1.51 mm; Length 150 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4002-0000 | Outer Diameter 0.97 mm; Length 150 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4003-0000 | Outer Diameter 2.04 mm; Length 135 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
| EXM-4004-0000 | Outer Diameter 2.37 mm; Length 110 cm; Lumen/Inner Diameter 0.014 in | Not stated | Available |
FDA clearances
- 510(k) K233668 December 2023
- 510(k) K221077 June 2022
- 510(k) K202835 December 2020
- 510(k) K181642 October 2018
Procedures that use atherectomy
Frequently asked questions
What is Auryon Atherectomy Catheter 1.5 mm OTW 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 1.5 mm OTW?
Auryon Atherectomy Catheter 1.5 mm OTW is made by Eximo Medical Ltd. It is listed under atherectomy devices in our device library.
What sizes does Auryon Atherectomy Catheter 1.5 mm OTW come in?
Sizes listed for Auryon Atherectomy Catheter 1.5 mm OTW: Outer Diameter: 0.97–2.37 mm; Length: 110–150 cm; Lumen/Inner Diameter: 0.01 in. Confirm availability with the manufacturer's instructions for use.
Is Auryon Atherectomy Catheter 1.5 mm OTW MRI safe?
The FDA device database entry for Auryon Atherectomy Catheter 1.5 mm OTW does not state its MRI safety status. Check the labeling before MRI.
Is Auryon Atherectomy Catheter 1.5 mm OTW FDA cleared?
Auryon Atherectomy Catheter 1.5 mm OTW is covered by FDA submissions K181642, K221077, K233668, K202835.
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.