K252652
- 510(k) number
- K252652
- Device name
- Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr
- Applicant
- Fortis Biosolutions Company Limited TW
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2026-05-14
- Date received
- 2025-08-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252652.pdf
Official FDA record: K252652
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.