SilverHawkTM P4034
by Covidien LP
SilverHawkTM P4034 is a Class II device made by Covidien LP, cleared under FDA 510(k) K061188 on 23 Oct 2006 and listed in FDA GUDID since 26 Aug 2016 (UDI-DI 00821684074084), 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 | Number00821684074084 | Date26 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061188 | Date23 Oct 2006 | StatusActive |
Official records
- AccessGUDID record 00821684074084
- FDA 510(k) database K061188
Across registries
- FDA 510(k) K061188 decided 23 Oct 2006 Active
- FDA GUDID UDI-DI 00821684074084 listed 26 Aug 2016 Listed
Recalls
-
- Terminated Z-1162-2010
ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk Cutter Drivers (Model Number FG 02550) because of damage to the packaging.
Timeline
- Cleared FDA 510(k) K061188
- Recall initiated FDA recalls Z-1162-2010
- Listed FDA GUDID 00821684074084
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SilverHawkTM
- Generic name
- Mechanical atherectomy system catheter, peripheral
- Model / reference
- P4034
- Primary DI / UDI-DI
- 00821684074084
- 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
- Sterilisation method
- Ethylene Oxide
Similar devices
Other devices filed under FDA product code MCW (Catheter, peripheral, atherectomy).
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- FreedomFlow Orbital Circumferential Atherectomy System by Cardio Flow Inc.,
- Pantheris System by AVINGER, INC.
- X-SIZER CATHETER SYSTEM by EV3, INC
- DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT by Cardiovascular Systems, Inc.
- 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 by Spectranetics Corporation
- JETSTREAM NAVITUS L SYSTEM by Pathway Medical Technologies, Inc.