510(k) K250404
K250404 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch". The FDA issued a decision of Substantially Equivalent on April 3, 2025. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2025
- Date Received
- February 12, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, For Peritoneal Dialysis, Disposable
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type