Turbohawk Peripheral Plaque Excision System
510(k) K111723
Turbohawk Peripheral Plaque Excision System is a Class II device made by EV3, Inc, cleared under FDA 510(k) K111723 on 27 Oct 2011, active as of 11 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111723 | Date27 Oct 2011 | StatusActive |
Official records
- FDA 510(k) database K111723
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
- Recall initiated FDA recalls Z-3022-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MCW
- FDA applicant
- Ev3, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.4875
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K111723
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| TurboHawk TH-LS-M | TH-LS-M | 00821684047156 | Length 6.0 cm; Outer Diameter 2.7 mm; Catheter Gauge 8 Fr | On the market |
| TurboHawk TH-LX-M | TH-LX-M | 00821684047149 | Outer Diameter 2.7 mm; Length 9.0 cm; Catheter Gauge 8 Fr | On the market |
| TurboHawk THS-LS-C | THS-LS-C | 00821684047217 | — | On the market |
| TurboHawk THS-LX-C | THS-LX-C | 00821684047200 | — | On the market |
| TurboHawk™ THS-LS-C | THS-LS-C | 00821684065785 | Catheter Gauge 7.0 Fr; Length 6.0 cm; Outer Diameter 2.7 mm | On the market |
| TurboHawk™ THS-LX-C | THS-LX-C | 00821684074008 | Length 9.0 cm; Catheter Gauge 7.0 Fr; Outer Diameter 2.7 mm | On the market |
Similar devices
Other devices filed under FDA product code MCW (Catheter, Peripheral, Atherectomy).
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- THROMCAT THROMBECTOMY CATHETER SYSTEM by Kensey Nash Corp.
- FOGARTY 160245F by Edwards Lifesciences LLC
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- JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) by Pathway Medical Technologies, Inc.