Cardio Systems, Inc.
Saint Paul, MN, US
Cardio Systems, Inc. appears in FDA device records in Saint Paul, MN. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Cardio Systems, Inc. between 1979 and 2013. The busiest year on record is 1979, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1985 | 1 |
| 1988 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1998 | 1 |
| 2008 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131092 | STEALTH 360 ORBITAL PAD SYSTEM | MCW | Substantially Equivalent | |
| K081944 | MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | MCW | Substantially Equivalent | |
| K972022 | ZAK-2000 | FNM | Substantially Equivalent | |
| K934689 | LOW AIR LOSS MATTRESS, MODIFICATION | INX | Substantially Equivalent | |
| K921500 | CENTRI-SAFE(TM) VALVE | MJJ | Substantially Equivalent | |
| K882177 | ADD-ON TO CRITICAL PATIENT CARE BED | IOQ | Substantially Equivalent | |
| K852736 | BAYLOR RAPID AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K792152 | CARDIOPLEGIA SOLUTION ADMIN. SET | DWF | Substantially Equivalent | |
| K792151 | OXYGENATOR GAS LINE FILTER | KRI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- CACApparatus, Autotransfusion
- INXBed, Air Fluidized
- IOQBed, Flotation Therapy, Powered
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- MCWCatheter, Peripheral, Atherectomy
- MJJCpb Check Valve, Retrograde Flow, In-Line
- FNMMattress, Air Flotation, Alternating Pressure
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain