FDA 510(k) Applications Submitted by CARDIO SYSTEMS, INC.
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K081944 | 07/08/2008 | MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | CARDIO SYSTEMS, INC. |
| K131092 | 04/18/2013 | STEALTH 360 ORBITAL PAD SYSTEM | CARDIO SYSTEMS, INC. |
| K972022 | 06/02/1997 | ZAK-2000 | CARDIO SYSTEMS, INC. |
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