The following data is part of a premarket notification filed by Cardiovascular Systems Inc. with the FDA for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System.
| Device ID | K190634 |
| 510k Number | K190634 |
| Device Name: | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Cardiovascular Systems Inc. 1225 Old Highway 8 NW St. Paul, MN 55112 |
| Contact | Kris Miller |
| Correspondent | Kris Miller Cardiovascular Systems Inc. 1225 Old Highway 8 NW St. 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 | 2019-03-12 |
| Decision Date | 2019-07-02 |