K250404

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

510(k) number: K250404
Device name: 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
Applicant: Fresenius Medical Care Renal Therapies Group, LLC MA · US
Product code: KDJ — Set, Administration, For Peritoneal Dialysis, Dispos
Decision date: 2025-04-03
Date received: 2025-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K250404.pdf

Official FDA record: K250404

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.