K242451
- 510(k) number
- K242451
- Device name
- HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
- Applicant
- Edwards Lifesciences CA · US
- Product code
- DYG — Catheter, Flow Directed
- Decision date
- 2024-12-09
- Date received
- 2024-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K242451.pdf
Official FDA record: K242451
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.