HawkOne Directional Atherectomy System
510(k) K161361
HawkOne Directional Atherectomy System is a Class II device made by Medtronic Vascular, Inc., cleared under FDA 510(k) K161361 on 14 Oct 2016, active as of 10 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161361 | Date14 Oct 2016 | StatusActive |
Official records
- FDA 510(k) database K161361
Recalls
-
- Terminated Z-0450-2022
- Terminated Z-0451-2022
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Timeline
- Cleared FDA 510(k) K161361
- Recall initiated FDA recalls Z-0450-2022
- Recall initiated FDA recalls Z-0451-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MCW
- Device class
- Class II
- Regulation
- 21 CFR Part 870.4875
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161361
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 | |||
|---|---|---|---|---|
| HawkOneTM H1-14550 | H1-14550 | 00821684073551 | No longer on the market | |
| HawkOne™ H1-14550 | H1-14550 | 00643169777644 | No longer on the market | |
| HawkOne™ H1-14550 | H1-14550 | 00763000835392 | On the market | |
| HawkOne™ H1-14550 | H1-14550 | 00643169968554 | On the market | |
| HawkOne™ H1-14550 | H1-14550 | 00763000202699 | No longer on the market | |
| HawkOne™ H1-M | H1-M | 00643169728769 | Length 129.0 cm; Outer Diameter 2.2 mm; Catheter Gauge 6.0 Fr | No longer on the market |
| HawkOne™ H1-M | H1-M | 00643169968332 | Catheter Gauge 6.0 Fr; Outer Diameter 2.2 mm; Length 129.0 cm | On the market |
| HawkOne™ H1-M | H1-M | 00643169792302 | Catheter Gauge 6.0 Fr; Length 129.0 cm; Outer Diameter 2.2 mm | No longer on the market |
| HawkOne™ H1-S | H1-S | 00643169968356 | Catheter Gauge 6.0 Fr; Outer Diameter 2.2 mm; Length 145.0 cm | On the market |
| HawkOne™ H1-S | H1-S | 00643169792319 | Catheter Gauge 6.0 Fr; Outer Diameter 2.2 mm; Length 145.0 cm | No longer on the market |
| HawkOne™ H1-S | H1-S | 00643169728783 | Length 145.0 cm; Outer Diameter 2.2 mm; Catheter Gauge 6.0 Fr | No longer on the market |
Similar devices
Other devices filed under FDA product code MCW (Catheter, Peripheral, Atherectomy).
- Rotablator Rotational Atherectomy System Guide Wire Line; HTI Floppy by Heart Technology, Inc.
- Auryon Atherectomy System by EXIMO MEDICAL LTD
- Turbo-Power (2.0mm) Laser Atherectomy Catheter, Turbo-Power (2.3mm) Laser Atherectomy Catheter by Spectranetics Corporation
- Pantheris SV by AVINGER, INC.
- Rotablator Rotational Atherectomy System With The Peripheral Rotalink Plus by Boston Scientific
- Jetstream G3 L System, Pv Console, Models PV31400, PV31300, PVCN100 by Pathway Medical Technologies, Inc.
- Intra-Operative TEC Atherectomy System by Intensive Technology, Inc.
- Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002 by Possis Medical, Inc.
- B-Laser Atherectomy System by EXIMO MEDICAL LTD
- Fogarty 160245F by Becton, Dickinson and Company