The following data is part of a premarket notification filed by Cardiovascular Systems, Inc. with the FDA for Stealth 360 Orbital Pad System.
| Device ID | K122987 |
| 510k Number | K122987 |
| Device Name: | STEALTH 360 ORBITAL PAD SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Contact | Maureen Mcdonnell |
| Correspondent | Maureen Mcdonnell 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 | 2012-09-26 |
| Decision Date | 2012-10-25 |
| Summary: | summary |