510(k) K243607
K243607 is an FDA 510(k) premarket notification submitted by Diality, Inc. for the device "Moda-flx Hemodialysis System Cartridge (102121-001 )". The FDA issued a decision of Substantially Equivalent on December 20, 2024. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Diality, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2024
- Date Received
- November 21, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type