K242143
- 510(k) number
- K242143
- Device name
- Angiography Injector
- Applicant
- Shandong Int Medical Instruments Co., Ltd. CN
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2024-12-23
- Date received
- 2024-07-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242143.pdf
Official FDA record: K242143
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.