TurboHawk™ THS-SS-C
by Covidien LP
TurboHawk™ THS-SS-C is a Class II device made by Covidien LP, cleared under FDA 510(k) K103618 on 5 Jan 2011 and listed in FDA GUDID since 13 Dec 2018 (UDI-DI 00821684065815), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00821684065815 | Date13 Dec 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103618 | Date5 Jan 2011 | StatusActive |
Official records
- AccessGUDID record 00821684065815
- FDA 510(k) database K103618
Across registries
- FDA 510(k) K103618 decided 5 Jan 2011 Active
- FDA GUDID UDI-DI 00821684065815 listed 13 Dec 2018 Listed
Timeline
- Cleared FDA 510(k) K103618
- Listed FDA GUDID 00821684065815
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TurboHawk™
- Generic name
- Mechanical atherectomy system catheter, peripheral
- Model / reference
- THS-SS-C
- Primary DI / UDI-DI
- 00821684065815
- 510(k) Number
- FDA product code
- MCW
- GMDN term
- Mechanical atherectomy system catheter, peripheral
- Device class
- Class II
- Regulation number
- 870.4875
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 3.9 CentimeterOuter Diameter — 2.2 MillimeterCatheter Gauge — 6.0 French
Similar devices
Other devices filed under FDA product code MCW (Catheter, peripheral, atherectomy).
- Pantheris LV Atherectomy Catheter by AVINGER, INC.
- Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire by Rex Medical, L.P.
- HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM by Covidien llc
- JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 by Pathway Medical Technologies, Inc.
- FOGARTY 160246F by Edwards Lifesciences LLC
- BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD by Baxter Edwards
- TurboHawk Plus Directional Atherectomy System by MEDTRONIC, INC.
- Rotarex Atherectomy System by Bard Peripheral Vascular, Inc.
- TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM by EV3, INC
- MICROTRACK by Devices For Vascular Intervention, Inc.