K233432
- 510(k) number
- K233432
- Device name
- 10F Sheath and Dilator Set
- Applicant
- Argon Medical Devices, Inc. TX · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2023-12-08
- Date received
- 2023-10-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233432.pdf
Official FDA record: K233432
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.