K241058
- 510(k) number
- K241058
- Device name
- Lyka® PORT Needle Free Access Device (4170Y)
- Applicant
- Quest Medical, Inc. TX · US
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2024-12-18
- Date received
- 2024-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241058.pdf
Official FDA record: K241058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.