HawkOne
Directional Atherectomy System, Large Vessel Extended Tip
3manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | MCW |
| Device type | Catheter, Peripheral, Atherectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4875 |
| 510(k) | K141801 |
| Record published | 2015-10-12 |
| Record revised | 2026-02-12 (version 8) |
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 | Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 28 °C; Storage environment temperature -20 to 140 °F; Handling environment atmospheric pressure 70 to 106 KiloPascal; Special storage condition: Keep dry |
| Sizes | Catheter gauge 6 to 7 Fr; outer diameter 2.2 to 2.6 mm; length 104 to 145 cm |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H1-M | Catheter Gauge 6.0 Fr | In distribution |
| H1-LS | Compatible guidewire.36 MM | In distribution |
| H1-LX | Catheter Gauge 7.0 Fr | In distribution |
| H1-14550 | In distribution | |
| H1-S | Compatible guidewire.36 MM | In distribution |
| H1-LX | Recommended Sheath,7,FR;Vessel Range,3.5-7.0,MM;Maximum Profile,2.6,MM;Compatible Guidewire,0.014,IN;Effective Length,104,CM;Tip Length,9.6,CM | Withdrawn |
| H1-M | Length 129.0 cm | Withdrawn |
| H1-14550 | Withdrawn | |
| H1-14550 | Withdrawn | |
| H1-S | Length 145.0 cm | Withdrawn |
| H1-M | Catheter Gauge 6.0 Fr | Withdrawn |
| H1-LS | Recommended Sheath,7,FR;Vessel Range,3.5-7.0,MM;Maximum Profile,2.6,MM;Compatible Guidewire,0.014,IN;Effective Length,107,CM;Tip Length,6.6,CM | Withdrawn |
| H1-S | Catheter Gauge 6.0 Fr | Withdrawn |
| H1-14550 | Withdrawn |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 |
| 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 |
| Peripheral Rotapro™ | Boston Scientific Corporation | 8 |
Showing 12 of 102. All products under Catheter, Peripheral, Atherectomy
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 | 2021-12-06 | Class I | Labeling design | Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. | 71,260 units | 2024-10-02 |
| ev3, Inc. | 510(k) number | 2021-12-06 | Class I | Labeling design | Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. | 28,094 units | 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.