K232788 is an FDA 510(k) clearance for the INSPIRA ART100. This device is classified as a Control, Pump Speed, Cardiopulmonary Bypass (Class II - Special Controls, product code DWA).
Submitted by Inspira Technologies Oxy B.H.N. , Ltd. (Ra’Anana, IL). The FDA issued a Cleared decision on May 24, 2024, 256 days after receiving the submission on September 11, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4380.
| 510(k) Number | K232788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2023 |
| Decision Date | May 24, 2024 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWA - Control, Pump Speed, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4380 |