HawkOne™ H1-S
HawkOne™ H1-S is a Class II device made by Covidien LP, cleared under FDA 510(k) K161361 on 14 Oct 2016 and listed in FDA GUDID since 26 Jan 2018 (UDI-DI 00643169968356), active as of 22 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 | GUDID listing | Number00643169968356 | Date26 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161361 | Date14 Oct 2016 | StatusActive |
Official records
- AccessGUDID record 00643169968356
- FDA 510(k) database K161361
Across registries
- FDA 510(k) K161361 decided 14 Oct 2016 Active
- FDA GUDID UDI-DI 00643169968356 listed 26 Jan 2018 Listed
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
- Listed FDA GUDID 00643169968356
- 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- Withdrawn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
- Trade name
- HawkOne™
- Generic name
- Mechanical atherectomy system catheter, peripheral
- Model / reference
- H1-S
- Primary DI / UDI-DI
- 00643169968356
- 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
- Catheter Gauge — 6.0 FrenchOuter Diameter — 2.2 MillimeterLength — 145.0 Centimeter
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- STEALTH 360 ORBITAL PAD SYSTEM by Cardiovascular Systems, Inc.
- ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS by Boston Scientific