Phoenix 1.8mm X 149cm 5f Atherectomy System
This Phoenix atherectomy configuration has a 1.8 mm cutting tip and a 149 cm working length for removing plaque from peripheral blood vessels. The sterile catheter advances over a guidewire…
This Phoenix atherectomy configuration has a 1.8 mm cutting tip and a 149 cm working length for removing plaque from peripheral blood vessels. The sterile catheter advances over a guidewire and is driven by a separate Phoenix handle. Use excludes the coronary, carotid, iliac and renal vessels.
Inside the handle, a battery-powered motor turns the catheter cutter. The catheter captures removed plaque and mechanically transports it back through the catheter and handle to an external collection reservoir. A slider switch on the handle starts and stops operation.
Vessel and Guidewire Requirements
The 5 French configuration is specified for vessels at least 2.5 mm in diameter. It uses a 0.014 inch exchange-length guidewire measuring at least 260 cm. The catheter is for single use.
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) | K143328 |
| Record published | 2016-09-01 |
| Record revised | 2024-08-21 (version 8) |
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 1.8 mm; length 149 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P18149K | Outer Diameter 1.8 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.