K242212
- 510(k) number
- K242212
- Device name
- Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
- Applicant
- Nemoto Kyorindo Co., Ltd. JP
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2024-08-27
- Date received
- 2024-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242212.pdf
Official FDA record: K242212
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.