The following data is part of a premarket notification filed by Cardiovascular Systems Inc. with the FDA for Viperwire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (pad), Diamondback 360 Peripheral Atherectomy System.
| Device ID | K180416 |
| 510k Number | K180416 |
| Device Name: | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Cardiovascular Systems Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112 |
| Contact | Susan Wolf |
| Correspondent | Susan Wolf Cardiovascular Systems Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-15 |
| Decision Date | 2018-04-17 |
| Summary: | summary |