Auryon
The Auryon system consists of a single-use catheter and a laser console. The catheter contains optical fibers and a blunt blade at its distal tip. The filing indicates the system and…
The Auryon system consists of a single-use catheter and a laser console. The catheter contains optical fibers and a blunt blade at its distal tip.
The filing indicates the system and catheters without aspiration for treatment, including atherectomy, of infra-inguinal stenoses and occlusions; it gives separate indications for catheters with aspiration.
Listed Item
Auryon Laser System 200-240V
Catheter Configurations
The catheter connects to the laser system and transmits energy to the narrowed or occluded artery. Catheter sizes listed range from 0.9 mm through 2.35 mm.
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Quasar Electronics Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
Record
| Listed by | Eximo Medical Ltd, Israel |
|---|---|
| FDA product code | MCW |
| Device type | Catheter, Peripheral, Atherectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4875 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K260244 |
| Record published | 2026-06-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Packaging | Wooden box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EXM-2002-1000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diamondback Peripheral | Cardiovascular Systems Incorporated | 44 |
| Turbo-Elite™ | Spectranetics Corp. | 24 |
| Stealth | Cardiovascular Systems Incorporated | 20 |
| Zilient | Cardiovascular Systems Incorporated | 16 |
| TurboHawk | Covidien LP | 15 |
| HawkOne | Covidien LP | 14 |
| Turbo-Elite Laser Atherectomy Catheter | Spectranetics Corp. | 12 |
| SilverHawk | Covidien LP | 11 |
| Auryon Atherectomy Catheter | Eximo Medical Ltd | 10 |
| Revolution Peripheral Atherectomy System | Rex Medical | 8 |
| Peripheral RotaLink® Plus | Boston Scientific Corporation | 8 |
| SilverHawkTM | Covidien LP | 8 |
Showing 12 of 102. All products under Catheter, Peripheral, Atherectomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260244 | 2026-04-10 |
| K241553 | 2024-06-27 |
| K233668 | 2023-12-15 |
| K230709 | 2023-06-09 |
| K220116 | 2022-09-26 |
| K221077 | 2022-06-09 |
| K202835 | 2020-12-02 |
| K181642 | 2018-10-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.