Phoenix 1.5mm X 149cm 4f Atherectomy System
The Phoenix 1.5 mm by 149 cm Atherectomy System removes plaque from peripheral blood vessels. It is a sterile, single-use system comprising a catheter, motorized handle and guidewire…
The Phoenix 1.5 mm by 149 cm Atherectomy System removes plaque from peripheral blood vessels. It is a sterile, single-use system comprising a catheter, motorized handle and guidewire support clip. It is not intended for coronary, carotid, iliac or renal vessels.
The tracking catheter passes directly over a guidewire and has no tip deflection capability. A battery-powered motor in the handle rotates the front cutter. Removed plaque travels back through the catheter and handle into a reservoir outside the patient. An on/off slider activates the device.
Guidewire Compatibility
The catheter uses a 0.014-inch exchange-length guidewire at least 260 cm long. The support clip holds the guidewire fixed relative to the handle to prevent it from rotating.
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 | Volcano Atheromed, Inc., United States |
|---|---|
| FDA product code | MCW |
| Device type | Catheter, Peripheral, Atherectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4875 |
| 510(k) | K211518 |
| Record published | 2021-10-26 |
| Record revised | 2024-08-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Sizes | Outer diameter 1.5 mm; length 149 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P15149K | 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 |
| 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 |
|---|---|
| K211518 | 2021-06-14 |
| K182972 | 2018-12-20 |
| K181877 | 2018-12-17 |
| K172386 | 2017-08-24 |
| K151145 | 2015-05-26 |
| K143328 | 2014-12-19 |
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.