K241410
- 510(k) number
- K241410
- Device name
- EDEN ControlCath
- Applicant
- Jmt Co., Ltd. KR
- Product code
- BSO — Catheter, Conduction, Anesthetic
- Decision date
- 2025-02-13
- Date received
- 2024-05-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241410.pdf
Official FDA record: K241410
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.