DeviceClearance

staysafe® catheter extension set with Safe- Lock, 12 inch +4 more— 510(k) K250404

Substantially Equivalent

Fresenius Medical Care Renal Therapies Group, LLC

FDA 510(k) clearance K250404 for staysafe® catheter extension set with Safe- Lock, 12 inch +4 more, Substantially Equivalent on 2025-04-03. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.

Clearance details

Device name as filed
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
Product code
Code KDJ
Device class
Class 2
Regulation
21 CFR 876.5630
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waltham, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KDJ

product code KDJ
Death
298
Injury
9,221
Malfunction
8,438
Other
1
Total
17,958

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.