The following data is part of a premarket notification filed by Cardiovascular Systems, Inc. with the FDA for Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad System.
| Device ID | K111388 |
| 510k Number | K111388 |
| Device Name: | DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Contact | Megan M Brandt |
| Correspondent | Megan M Brandt CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR. 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 | 2011-05-17 |
| Decision Date | 2011-07-26 |
| Summary: | summary |