K231248 is an FDA 510(k) clearance for the Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Edwards Lifesciencess, LLC (Irvine, US). The FDA issued a Cleared decision on September 21, 2023, 143 days after receiving the submission on May 1, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K231248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2023 |
| Decision Date | September 21, 2023 |
| Days to Decision | 143 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 |