K230364 is an FDA 510(k) clearance for the VitalFlow™ Console. This device is classified as a Blood Pump For Ecmo, Long-term (> 6 Hours) Use (Class II - Special Controls, product code QNR).
Submitted by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) (Dexter, US). The FDA issued a Cleared decision on August 25, 2023, 196 days after receiving the submission on February 10, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4100. A Blood Pump For Long-term Circulatory Support Is A Device Intended For Use As Part Of An Extracorporeal Circuit Intended To Provide Assisted Extracorporeal Circulation And Physiologic Gas Exchange Of The Patient's Blood In Patients With Acute Respiratory Failure Or Acute Cardiopulmonary Failure Where Other Available Treatment Options Have Failed And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent..
| 510(k) Number | K230364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2023 |
| Decision Date | August 25, 2023 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QNR - Blood Pump For Ecmo, Long-term (> 6 Hours) Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4100 |
| Definition | A Blood Pump For Long-term Circulatory Support Is A Device Intended For Use As Part Of An Extracorporeal Circuit Intended To Provide Assisted Extracorporeal Circulation And Physiologic Gas Exchange Of The Patient's Blood In Patients With Acute Respiratory Failure Or Acute Cardiopulmonary Failure Where Other Available Treatment Options Have Failed And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent. |