K202751 is an FDA 510(k) clearance for the TandemHeart Pump and Escort Controller. This device is classified as a Blood Pump For Ecmo, Long-term (> 6 Hours) Use (Class II - Special Controls, product code QNR).
Submitted by Cardiacassist, Inc. (Pittsburg, US). The FDA issued a Cleared decision on March 26, 2021, 186 days after receiving the submission on September 21, 2020.
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 | K202751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2020 |
| Decision Date | March 26, 2021 |
| Days to Decision | 186 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. |