TurboHawk™ Plus
TurboHawk Plus is a directional atherectomy catheter for removing plaque from native peripheral arteries. A rotating blade within a distal housing shaves occlusive material as the catheter…
TurboHawk Plus is a directional atherectomy catheter for removing plaque from native peripheral arteries. A rotating blade within a distal housing shaves occlusive material as the catheter advances, and the removed tissue collects in the tip. A battery-powered cutter driver operates the catheter.
The system treats new or recurrent calcified and noncalcified atherosclerotic lesions. It tracks over a 0.014-inch guidewire. Use is excluded from coronary, carotid, iliac and renal vessels, and treatment of severely calcified lesions requires the SpiderFX embolic protection device.
Listed Item
Atherectomy THP-LS TH Plus 7F STD TIP US
Cutting Controls
A thumb lever positions and engages the cutter, while a separate switch powers the driver. Moving the lever distally stops the drive shaft and disengages the blade; full distal movement packs excised tissue into the tip. The collection-and-cutting sequence may be repeated during the procedure.
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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | MCW |
| Device type | Catheter, Peripheral, Atherectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4875 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K212027 |
| Record published | 2021-09-26 |
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 |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight; Storage environment temperature -29 to 60 °C; Special storage condition: Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Sizes | Catheter gauge 6 to 7 Fr; length 104 to 145 cm; balloon diameter 2.2 to 2.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| THP-LS | Catheter Gauge 7.0 Fr | In distribution |
| THP-S | Compatible guidewire 0.36MM | In distribution |
| THP-M | Balloon Diameter 2.2 mm | In distribution |
| THP-LX | Compatible guidewire 0.36MM | 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 |
|---|---|
| K212027 | 2021-08-24 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | 510(k) number | 2022-02-04 | Class I | Labeling design | The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization. | 441 devices | 2024-10-02 |
| ev3, Inc. | 510(k) number | 2022-02-04 | Class I | Labeling design | The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization. | 245 devices | 2024-10-02 |
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.