TurboHawk TH-LS-M
by Covidien LP
TurboHawk TH-LS-M is a Class II device made by Covidien LP, cleared under FDA 510(k) K111723 on 27 Oct 2011 and listed in FDA GUDID since 12 Oct 2015 (UDI-DI 00821684047156), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00821684047156 | Date12 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111723 | Date27 Oct 2011 | StatusActive |
Official records
- AccessGUDID record 00821684047156
- FDA 510(k) database K111723
Across registries
- FDA 510(k) K111723 decided 27 Oct 2011 Active
- FDA GUDID UDI-DI 00821684047156 listed 12 Oct 2015 Listed
Recalls
-
- Terminated Z-3022-2018
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.
Timeline
- Cleared FDA 510(k) K111723
- Listed FDA GUDID 00821684047156
- Recall initiated FDA recalls Z-3022-2018
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- Withdrawn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
- TH-LS-M
- Primary DI / UDI-DI
- 00821684047156
- 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 — 6.0 CentimeterOuter Diameter — 2.7 MillimeterCatheter Gauge — 8 French
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- FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) by Cardio Flow Inc.,
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