K241109
- 510(k) number
- K241109
- Device name
- Single-use Sterile High-pressure Angiographic Syringes and Accessories
- Applicant
- Shenzhen Boon Medical Supply Co., Ltd. CN
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2024-08-22
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241109.pdf
Official FDA record: K241109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.