Laser System
200-240 Vac Laser system For Infra Inguinal Atherectomy
3manufacturers in China registered for this device type
2catalogue numbers in this listing
8510(k) clearances naming this product code
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) | K181642 |
| Record published | 2019-03-22 |
| Record revised | 2024-11-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Packaging | Wooden box |
| Distribution end date | 2023-12-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EXM-2001-1000 | Withdrawn | |
| EXM-2001-1100 | Withdrawn |
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.