The following data is part of a premarket notification filed by Cardiovascular Systems, Inc. with the FDA for Diamondback 360 Degree Orbital Atherectomy System With Viperslide Lubricant.
| Device ID | K082981 |
| 510k Number | K082981 |
| Device Name: | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Contact | David D Brooke |
| Correspondent | David D Brooke CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR. St. 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 | 2008-10-06 |
| Decision Date | 2008-10-31 |
| Summary: | summary |