Company ยท US
Cardio Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2013. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 2 |
| CAC | Apparatus, Autotransfusion | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 |
| INX | Bed, Air Fluidized | 1 |
| IOQ | Bed, Flotation Therapy, Powered | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2013 | K131092 | STEALTH 360 ORBITAL PAD SYSTEM Cardio Systems, Inc. | MCW |
| Aug 14, 2008 | K081944 | MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM Cardio Systems, Inc. | MCW |
| Jan 22, 1998 | K972022 | ZAK-2000 Cardio Systems, Inc. | FNM |
| Feb 2, 1994 | K934689 | LOW AIR LOSS MATTRESS, MODIFICATION Cardio Systems, Inc. | INX |
| Sep 15, 1992 | K921500 | CENTRI-SAFE(TM) VALVE Cardio Systems, Inc. | MJJ |
| Dec 1, 1988 | K882177 | ADD-ON TO CRITICAL PATIENT CARE BED Cardio Systems, Inc. | IOQ |
| Sep 18, 1985 | K852736 | BAYLOR RAPID AUTOTRANSFUSION SYSTEM Cardio Systems, Inc. | CAC |
| Nov 13, 1979 | K792152 | CARDIOPLEGIA SOLUTION ADMIN. SET Cardio Systems, Inc. | DWF |
| Nov 13, 1979 | K792151 | OXYGENATOR GAS LINE FILTER Cardio Systems, Inc. | KRI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||