K232480 is an FDA 510(k) clearance for the ProtekDuo Veno-Venous Cannula Sets. This device is classified as a Dual Lumen Ecmo Cannula (Class II - Special Controls, product code PZS).
Submitted by Cardiacassist, Inc. (Pittsburg, US). The FDA issued a Cleared decision on October 6, 2023, 51 days after receiving the submission on August 16, 2023.
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 | K232480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2023 |
| Decision Date | October 06, 2023 |
| Days to Decision | 51 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. |