The following data is part of a premarket notification filed by Cardio Systems, Inc. with the FDA for Modification To Diamondback 360 Degree Orbital Atherectomy System.
| Device ID | K081944 |
| 510k Number | K081944 |
| Device Name: | MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | CARDIO SYSTEMS, INC. 651 CAMPUS DRIVE Saint Paul, MN 55112 -3495 |
| Contact | David D Brooke |
| Correspondent | David D Brooke 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 | 2008-07-08 |
| Decision Date | 2008-08-14 |
| Summary: | summary |