Auryon Atherectomy Catheter
Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW - Hydrophilic Coating
3manufacturers in China registered for this device type
10catalogue 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) | K220116 |
| Record published | 2022-10-04 |
| Record revised | 2026-06-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -18 to 60 °C |
| Sizes | Outer diameter 0.9 to 2.35 mm; length 110 to 225 cm; lumen/inner diameter 0.014 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EXM-4003-H000 | Outer Diameter 2 mm | In distribution |
| EXM-4002-H000 | Outer Diameter 0.9 mm | In distribution |
| EXM-4010-0000 | Outer Diameter 1.5 mm | In distribution |
| EXM-4012-0000 | Outer Diameter 1.7 mm | In distribution |
| EXM-4011-H000 | Outer Diameter 0.9 mm | In distribution |
| EXM-4004-H000 | Outer Diameter 2.35 mm | In distribution |
| EXM-4012-H000 | Outer Diameter 1.7 mm | In distribution |
| EXM-4011-0000 | Outer Diameter 0.9 mm | In distribution |
| EXM-4010-H000 | Outer Diameter 1.5 mm | In distribution |
| EXM-4001-H000 | Outer Diameter 1.5 mm | 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 |
| Revolution Peripheral Atherectomy System | Rex Medical | 8 |
| Peripheral RotaLink® Plus | Boston Scientific Corporation | 8 |
| SilverHawkTM | Covidien LP | 8 |
| Peripheral Rotapro™ | Boston Scientific Corporation | 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 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2024-11-25 | Class II | Under Investigation by firm | Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode. | 138 units |
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.