The following data is part of a premarket notification filed by Medtronic Vascular, Inc. with the FDA for Silverhawk Peripheral Plaque Excision System, Turbohawk Peripheral Plaque Excision System.
| Device ID | K170191 |
| 510k Number | K170191 |
| Device Name: | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | MEDTRONIC VASCULAR, INC. 3033 CAMPUS DRIVE Plymouth, MN 55441 |
| Contact | Aaron Hage |
| Correspondent | Aaron Hage MEDTRONIC VASCULAR, INC. 3033 CAMPUS DRIVE Plymouth, MN 55441 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-23 |
| Decision Date | 2017-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169968547 | K170191 | 000 |
| 00763000918941 | K170191 | 000 |
| 00763000918958 | K170191 | 000 |
| 00763000918910 | K170191 | 000 |
| 00763000918927 | K170191 | 000 |
| 00763000918965 | K170191 | 000 |
| 00643169968202 | K170191 | 000 |
| 00643169968226 | K170191 | 000 |
| 00643169968400 | K170191 | 000 |
| 00643169968424 | K170191 | 000 |
| 00643169968431 | K170191 | 000 |
| 00643169968448 | K170191 | 000 |
| 00643169968455 | K170191 | 000 |
| 00643169968462 | K170191 | 000 |
| 00643169968479 | K170191 | 000 |
| 00763000918934 | K170191 | 000 |