K203409 is an FDA 510(k) clearance for the MC3 Crescent Jugular Dual Lumen Catheter. This device is classified as a Dual Lumen Ecmo Cannula (Class II - Special Controls, product code PZS).
Submitted by Mc3, Inc. (Dexter, US). The FDA issued a Cleared decision on May 3, 2021, 165 days after receiving the submission on November 19, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4100. Long Term Support Greater Than 6 Hours For Acute Respiratory 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 | K203409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2020 |
| Decision Date | May 03, 2021 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PZS - Dual Lumen Ecmo Cannula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4100 |
| Definition | Long Term Support Greater Than 6 Hours For Acute Respiratory Or Acute Cardiopulmonary Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent. |