The following data is part of a premarket notification filed by Cardiovascular System, Inc. with the FDA for Viperwire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital Pad.
| Device ID | K151260 |
| 510k Number | K151260 |
| Device Name: | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Cardiovascular System, Inc. 1228 Old Highway 8 NW Saint Paul, MN 55112 |
| Contact | Kim Wallner |
| Correspondent | Kim Wallner Cardiovascular System, Inc. 1228 Old Highway 8 NW Saint Paul, MN 55112 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-12 |
| Decision Date | 2015-06-10 |
| Summary: | summary |