K251788
- 510(k) number
- K251788
- Device name
- Extension tube
- Applicant
- Zhuhai DR Medical Instruments Co., Ltd. CN
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2026-03-05
- Date received
- 2025-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251788.pdf
Official FDA record: K251788
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.