The following data is part of a premarket notification filed by Cardio Systems, Inc. with the FDA for Stealth 360 Orbital Pad System.
| Device ID | K131092 |
| 510k Number | K131092 |
| Device Name: | STEALTH 360 ORBITAL PAD SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | CARDIO SYSTEMS, INC. 651 CAMPUS DRIVE Saint Paul, MN 55112 -3495 |
| Contact | Maureen Mcdonnell |
| Correspondent | Maureen Mcdonnell CARDIO SYSTEMS, INC. 651 CAMPUS DRIVE Saint Paul, MN 55112 -3495 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-18 |
| Decision Date | 2013-06-24 |
| Summary: | summary |