stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter ex…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173593 FDA 510(k)
- FDA Product Code
- KDJ 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)
The Stay-Safe Catheter Extension Set is a disposable device used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay-safe PIN technology. It is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis in a healthcare facility or at home.
The device is supplied as a sterile, single-use product and should not be used if the package is damaged or caps are not in place. It is available in multiple lengths including 6 inch, 12 inch, 18 inch, and 4 inch adapter configurations. The device has FDA 510(k) clearance with product code KDJ and is classified under regulation number 876.5630.
Frequently asked questions
What is the Stay-Safe Catheter Extension Set used for?
The Stay-Safe Catheter Extension Set is a disposable device used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay-safe PIN technology. It is indicated for patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis in healthcare facilities or at home.
How is the Stay-Safe Catheter Extension Set supplied and is it reusable?
The device is supplied as a sterile, single-use product and should not be used if the package is damaged or caps are not in place. It is designed for one-time use only to ensure patient safety and prevent contamination.
What lengths and configurations are available for the Stay-Safe Catheter Extension Set?
The Stay-Safe Catheter Extension Set is available in multiple lengths including 6 inch, 12 inch, 18 inch, and a 4 inch adapter configuration. These different lengths allow for flexibility in various clinical settings and patient needs.
What is the regulatory status of the Stay-Safe Catheter Extension Set?
The device has FDA 510(k) clearance with product code KDJ and is classified under regulation number 876.5630. This clearance indicates that the device is substantially equivalent to other legally marketed devices in its class.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Side B - freseniusmedicalcare.com, stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe ..., Stay•safe Catheter Extension Set With Safe-Lock, 12… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173593 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA 510(k) K173593 24 fields · synced Sep 27, 2026