The following data is part of a premarket notification filed by Cardiovascualr Systems Inc. with the FDA for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series.
| Device ID | K220568 |
| 510k Number | K220568 |
| Device Name: | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Cardiovascualr Systems Inc. 1225 Old Highway 8 NW New Brighton, MN 55112 |
| Contact | Kris Miller |
| Correspondent | Kris Miller Cardiovascualr Systems Inc. 1225 Old Highway 8 NW New Brighton, 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 | 2022-02-28 |
| Decision Date | 2022-04-27 |