Atherectomy
1.5 mm OTW B-Laser 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.
1.5 mm OTW B-Laser 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-4001-0000 | — | Not stated | Available |
| EXM-4002-0000 | — | Not stated | Available |
| EXM-4003-0000 | — | Not stated | Available |
| EXM-4004-0000 | — | Not stated | Available |
FDA clearances
- 510(k) K181642 October 2018
Procedures that use atherectomy
Frequently asked questions
What is 1.5 mm OTW B-Laser 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 1.5 mm OTW B-Laser catheter?
1.5 mm OTW B-Laser catheter is made by Eximo Medical Ltd. It is listed under atherectomy devices in our device library.
What sizes does 1.5 mm OTW B-Laser catheter come in?
The FDA device database does not list sizes for 1.5 mm OTW B-Laser catheter. Check the instructions for use or ask a Eximo Medical Ltd representative.
Is 1.5 mm OTW B-Laser catheter MRI safe?
The FDA device database entry for 1.5 mm OTW B-Laser catheter does not state its MRI safety status. Check the labeling before MRI.
Is 1.5 mm OTW B-Laser catheter FDA cleared?
1.5 mm OTW B-Laser catheter is covered by FDA submission K181642.
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.