Peritoneal Dialysis Catheters
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K863128 FDA 510(k)
- FDA Product Code
- FJS 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 Peritoneal Dialysis Catheters are long-term indwelling peritoneal catheters designed for repeated access through the peritoneal membrane. These devices facilitate peritoneal dialysis by providing a conduit for dialysate exchange, enabling the removal of waste products and excess fluids from the body in patients with renal failure. Constructed for sustained use, they are intended to maintain reliable and secure access over extended periods, supporting continuous or intermittent dialysis therapies.
These catheters are supplied sterile and intended for single-use implantation, though they are designed for long-term indwelling use in peritoneal dialysis patients. They are classified under FDA regulation number 876.5630 and fall under device class II. The devices are regulated through the FDA’s 510(k) clearance process, with this submission reviewed by the Gastroenterology and Urology advisory committee. No MRI safety information is specified, and sizes or additional technical specifications are not detailed in the provided data.
Frequently asked questions
What is the primary purpose of the Peritoneal Dialysis Catheters by Thermedics, Inc.?
These catheters are designed specifically for repeated access through the peritoneal membrane to facilitate peritoneal dialysis. They provide a conduit for dialysate exchange, enabling the removal of waste products and excess fluids in patients with renal failure. Their long-term indwelling design ensures continuous or intermittent dialysis support over extended periods.
Are the Peritoneal Dialysis Catheters supplied sterile and intended for single-use or reuse?
The catheters are supplied sterile and intended for single-use implantation. However, they are engineered for long-term indwelling use once implanted in peritoneal dialysis patients, meaning they remain in place for the duration of the treatment rather than being discarded after each use.
What regulatory pathway does the Peritoneal Dialysis Catheter follow, and which advisory committee reviewed it?
The device follows the FDA’s 510(k) clearance process and is classified under FDA regulation number 876.5630 as a Class II medical device. It was reviewed by the Gastroenterology and Urology advisory committee, specifically the GU (Gastroenterology, Urology) committee, during its clearance process.
Are there any specific size or technical specifications mentioned for these catheters?
The provided data does not include detailed specifications regarding sizes or technical measurements for the Peritoneal Dialysis Catheters. Additional information on dimensions or technical features would need to be referenced from the manufacturer’s product documentation or technical specifications.
Can these catheters be used in MRI environments?
The provided data does not specify any MRI safety information for the Peritoneal Dialysis Catheters. If MRI compatibility is required, it is recommended to consult the manufacturer’s instructions or additional technical documentation for guidance.
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: PERITONEAL DIALYSIS CATHETERS (K863128) — FDA 510(k) | Innolitics, ACUTE PERITONEAL DIALYSIS CATHETERS (K854966) — FDA 510(k) | Innolitics, Peritoneal access catheter - Thermedics, Inc., Flex-Neck® Peritoneal Dialysis (PD) Catheters | Merit Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K863128 | Class II | Active |
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Manufacturer
- Manufacturer
- Thermedics, Inc.
Sources (1)
- FDA 510(k) K863128 24 fields · synced Oct 1, 2026