K240534 is an FDA 510(k) clearance for the Bio-Medicus Life Support Catheter and Introducer. This device is classified as a Single Lumen Ecmo Cannula (Class II - Special Controls, product code QHW).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on April 19, 2024, 53 days after receiving the submission on February 26, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4100. Single-lumen Cannulas/catheters To Be Used With An Extracorporeal Circuit Intended For Use 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 | K240534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2024 |
| Decision Date | April 19, 2024 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QHW — Single Lumen Ecmo Cannula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4100 |
| Definition | Single-lumen Cannulas/catheters To Be Used With An Extracorporeal Circuit Intended For Use 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. |