K242909
- 510(k) number
- K242909
- Device name
- FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- DRS — Transducer, Blood-Pressure, Extravascular
- Decision date
- 2025-03-21
- Date received
- 2024-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242909.pdf
Official FDA record: K242909
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.