510(k) K241410
K241410 is an FDA 510(k) premarket notification submitted by Jmt Co., Ltd. for the device "EDEN ControlCath". The FDA issued a decision of Substantially Equivalent on February 13, 2025. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Jmt Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2025
- Date Received
- May 17, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Conduction, Anesthetic
- Device Class
- Class II
- Regulation Number
- 868.5120
- Review Panel
- AN
- Submission Type