The following data is part of a premarket notification filed by Cardiovascular Systems Inc. with the FDA for Diamondback 360 Peripheral Orbital Atherectomy System.
| Device ID | K152694 |
| 510k Number | K152694 |
| Device Name: | Diamondback 360 Peripheral Orbital Atherectomy System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Cardiovascular Systems Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112 |
| Contact | Kim Wallner |
| Correspondent | Kim Wallner 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2015-10-21 |