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stay•safe® catheter extension set with Safe- Lock, 12 inch +4 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250404

by Fresenius Medical Care Renal Therapies Group, LLC

Identifiers

510(k) Number
K250404 FDA 510(k)
FDA Product Code
KDJ FDA 510(k)
Models / Variants
stay•safe® catheter extension set with Safe- Lock, 12 inch FDA 510(k)
stay•safe® catheter extension set with Luer-Lock, 6 inch FDA 510(k)
stay•safe® catheter extension set with Luer-Lock, 12 inch FDA 510(k)
stay•safe® catheter extension set with Luer-Lock, 18 inch FDA 510(k)
stay•safe® to Luer-Lock Adapter, 4 inch FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5630 FDA 510(k)
Regulation Number
876.5630 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

stay•safe® catheter extension set with Safe- Lock, 12 inch +4 more models by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA_510K — listed…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC

Sources (1)

  • FDA 510(k) K250404 24 fields · synced Jun 18, 2026