K253048
- 510(k) number
- K253048
- Device name
- High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- Applicant
- Shenzhen Maiwei Biotech Co., Ltd. CN
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2026-04-16
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K253048.pdf
Official FDA record: K253048
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.