K222766
- 510(k) number
- K222766
- Device name
- Disposable Extension Set
- Applicant
- Shandong Ande Healthcare Apparatus Co., Ltd. CN
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2024-04-12
- Date received
- 2022-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K222766.pdf
Official FDA record: K222766
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.