SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
FDA 510(k) clearance K170191 · decided 2017-06-16
Clearance details
- K-number
- K170191
- Device name
- SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
- Applicant
- Medtronic Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-23
- Decision date
- 2017-06-16
- Days to decision
- 144 days
- Clearance type
- Special
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic Vascular
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Protégé GPS Self-expanding Peripheral Stent System (P060001/S053) | Medtronic Vascular, Inc. | 2025-12-16 |
| Abre Venous Self-expanding Stent System (P200026/S015) | Medtronic Vascular, Inc. | 2025-12-12 |
| Protégé GPS self-expanding Peripheral Stent System (P060001/S052) | Medtronic Vascular, Inc. | 2025-11-07 |
| EverFlex self-expanding Peripheral Stent System (EverFlex) (P110023/S061) | Medtronic Vascular, Inc. | 2025-11-07 |
| EverFlex Self-expanding Peripheral Stent System (P110023/S062) | Medtronic Vascular, Inc. | 2025-10-02 |
| VenaSeal Closure System (P140018/S047) | Medtronic Vascular, Inc. | 2025-09-26 |
| Abre Venous Self-expanding Stent System (P200026/S014) | Medtronic Vascular, Inc. | 2025-09-23 |
| VenaSeal Closure System (P140018/S046) | Medtronic Vascular, Inc. | 2025-09-23 |