HawkOneTM H1-14550
by Covidien LP
HawkOneTM H1-14550 is a Class II device made by Covidien LP, cleared under FDA 510(k) K161361 on 14 Oct 2016 (1 earlier submission) and listed in FDA GUDID since 26 Aug 2016 (UDI-DI 00821684073551), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 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 |
| United States | GUDID listing | Number00821684073551 | Date26 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 00821684073551
- FDA 510(k) database K161361
- FDA 510(k) database K141801
Across registries
- FDA 510(k) K161361 decided 14 Oct 2016 Active
- FDA GUDID UDI-DI 00821684073551 listed 26 Aug 2016 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) K141801
- Listed FDA GUDID 00821684073551
- 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- Withdrawn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
- Trade name
- HawkOneTM
- Generic name
- Mechanical atherectomy system catheter, peripheral
- Model / reference
- H1-14550
- Primary DI / UDI-DI
- 00821684073551
- FDA product code
- MCW
- GMDN term
- Mechanical atherectomy system catheter, peripheral
- Device class
- Class II
- Regulation number
- 870.4875
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Radiation Sterilization
Similar devices
Other devices filed under FDA product code MCW (Catheter, peripheral, atherectomy).
- B-Laser Atherectomy System by EXIMO MEDICAL LTD
- Fogarty 160245F by Becton, Dickinson and Company
- Pantheris System by AVINGER, INC.
- Pantheris Catheter (8F); Pantheris Catheter (7F); Lightbox HS Imaging Console; Lightbox Sled by AVINGER, INC.
- Turbo-Tandem System Model 472-110 by Spectranetics Corporation
- Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems, Inc.
- ARROW-TREROTOLA PTD CATHETER by Arrow Intl., Inc.
- XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL by Xtrak Medical, Inc.
- POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER, MODEL 3030C, LF140 CATHETER, MODEL 3040C, PUMP SET 3020P by Possis Medical, Inc.
- STEALTH 360 ORBITAL PAD SYSTEM by Cardiovascular Systems, Inc.