K244038
- 510(k) number
- K244038
- Device name
- High Pressure Tubing
- Applicant
- Shandong Int Medical Instruments Co., Ltd. CN
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2025-09-05
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K244038.pdf
Official FDA record: K244038
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.