TurboHawk
Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC Technology
3manufacturers in China registered for this device type
15catalogue 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) | K111723 |
| Record published | 2015-10-12 |
| Record revised | 2024-05-02 (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 | Special storage condition: Keep dry |
| Sizes | Length 3.9 to 145 cm; outer diameter 2.2 to 2.7 mm; catheter gauge 6 to 8 Fr |
| Distribution end date | 2019-03-10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| THS-LX-C | In distribution | |
| THS-SS-CL | Length 3.9 cm | In distribution |
| THS-LX-C | Max. Guidewire,.36 mm | In distribution |
| THS-SS-C | Length 3.9 cm | In distribution |
| THS-SS-C | Length 3.9 cm | In distribution |
| THS-SS-CL | Length 3.9 cm | In distribution |
| TH-LS-M | Length 6.0 cm | In distribution |
| THS-SS-CL | Catheter Gauge 6.0 Fr | In distribution |
| THS-SX-C | Max. Guidewire,.36 mm | In distribution |
| THS-SX-C | Length 5.9 cm | In distribution |
| THS-LS-C | Catheter Gauge 7.0 Fr | In distribution |
| THS-SX-C | Catheter Gauge 6.0 Fr | In distribution |
| THS-LS-C | In distribution | |
| TH-LX-M | Outer Diameter 2.7 mm | In distribution |
| TH-LX-M | Catheter Gauge 8.0 Fr | Withdrawn |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 |
| 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 |
| Peripheral Rotapro™ | Boston Scientific Corporation | 8 |
Showing 12 of 102. All products under Catheter, Peripheral, Atherectomy
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 | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2018-08-10 | Class II | Process control | The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter. | 67 units | 2020-08-04 |
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.