SilverHawkTM P4033
by Covidien LP
SilverHawkTM P4033 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 00821684074060), 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 | Number00821684074060 | Date26 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061188 | Date23 Oct 2006 | StatusActive |
Official records
- AccessGUDID record 00821684074060
- FDA 510(k) database K061188
Across registries
- FDA 510(k) K061188 decided 23 Oct 2006 Active
- FDA GUDID UDI-DI 00821684074060 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 00821684074060
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- Withdrawn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
- P4033
- Primary DI / UDI-DI
- 00821684074060
- 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).
- Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire by Rex Medical, L.P.
- HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM by Covidien llc
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- FOGARTY 160246F by Edwards Lifesciences LLC
- BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD by Baxter Edwards
- TurboHawk Plus Directional Atherectomy System by MEDTRONIC, INC.
- Rotarex Atherectomy System by Bard Peripheral Vascular, Inc.
- TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM by EV3, INC
- MICROTRACK by Devices For Vascular Intervention, Inc.
- JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 by Pathway Medical Technologies, Inc.