K242451 is an FDA 510(k) clearance for the HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1). This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on December 9, 2024, 115 days after receiving the submission on August 16, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K242451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2024 |
| Decision Date | December 09, 2024 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYG - Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |