K230528
- 510(k) number
- K230528
- Device name
- Extension Set
- Applicant
- Medcaptain Life Science Co., Ltd. CN
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2023-12-01
- Date received
- 2023-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230528.pdf
Official FDA record: K230528
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.