K242612
- 510(k) number
- K242612
- Device name
- Option ELITE Vena Cava Filter System (352506070E 352506100E)
- Applicant
- Argon Medical Devices, Inc. TX · US
- Product code
- DTK — Filter, Intravascular, Cardiovascular
- Decision date
- 2024-09-10
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.5 MB · U.S. public domain
Also available from FDA: K242612.pdf
Official FDA record: K242612
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.