The following data is part of a premarket notification filed by Cardiovascular Systems Incorporated with the FDA for Diamondback 360 Peripheral Orbital Atherectomy System.
| Device ID | K133399 |
| 510k Number | K133399 |
| Device Name: | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | CARDIOVASCULAR SYSTEMS INCORPORATED 651 CAMPUS DR. Saint Paul, MN 55112 |
| Contact | Blair Buth |
| Correspondent | Blair Buth CARDIOVASCULAR SYSTEMS INCORPORATED 651 CAMPUS DR. 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 | 2013-11-06 |
| Decision Date | 2013-11-22 |
| Summary: | summary |