Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dial…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Covidien llc
Identity
- Trade Name
- Argyle EUDAMED
- Device Name
- GASTRIC LAVAGE KIT SMALL EUDAMED
- Model / Reference
- 1100752102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20884521133553 EUDAMED
- Basic UDI-DI
- B-20884521133553 EUDAMED
- 510(k) Number
- K180485 FDA 510(k)
- FDA Product Code
- FJS FDA 510(k)
- EMDN Code
- G0299 GASTROINTESTINAL TUBES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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
- SESK Substantially Equivalent — Kit FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Argyle Peritoneal Dialysis Catheter and Kits are classified as Catheter, Peritoneal, Long-Term Indwelling, designed for continuous or intermittent peritoneal dialysis. These devices facilitate fluid exchange within the peritoneal cavity to manage end-stage renal disease by providing a sterile, indwelling pathway for dialysate infusion and drainage. The Presternal Catheter variant is positioned subcutaneously near the sternum, while accessory components like the Titanium Luer Adapter and Catheter Extender enhance compatibility and usability in clinical settings.
These devices are supplied as sterile, single-use or reusable systems depending on the accessory configuration, with titanium components ensuring durability and MRI safety. Sizes and configurations vary by model, adhering to regulatory standards under FDA 510K and MDD compliance. They are intended for use in hospital or home dialysis programs, requiring proper aseptic technique during insertion and maintenance. Authorisations include FDA clearance and MDD conformity, with product codes and registration numbers ensuring traceability in medical records.
Frequently asked questions
What clinical specialties are these peritoneal dialysis catheters primarily associated with based on regulatory filings?
These catheters are primarily associated with the specialties of gastroenterology and urology, as indicated by the advisory committee descriptions (GU) and medical specialty filings in the regulatory data. This reflects their use in procedures involving both the gastrointestinal tract (for peritoneal access) and urinary system (for dialysis-related care).
Are the titanium components of these catheters safe for use in MRI environments, and why?
Yes, the titanium components are designed for MRI safety, as explicitly stated in the device description. Titanium is non-ferromagnetic and does not interfere with magnetic resonance imaging, making it suitable for patients who require both dialysis and MRI scans.
How are these catheters supplied, and what does that mean for clinical workflows?
The Argyle Peritoneal Dialysis Catheter and Kits are supplied as sterile systems, with some accessories (like the Titanium Luer Adapter and Extender) available as single-use or reusable components depending on the configuration. This allows flexibility in clinical settings—single-use items reduce infection risk, while reusable accessories may lower costs for high-volume programs. Proper aseptic technique is required during insertion and maintenance, as noted in the description.
What size variations or configurations should clinicians expect when selecting these catheters?
The catheters come in multiple sizes and configurations, tailored to patient needs and dialysis protocols. While exact dimensions aren’t specified here, the regulatory data confirms adherence to FDA 510K and MDD standards, ensuring compliance with established safety and performance requirements. The Presternal variant, for example, is positioned subcutaneously near the sternum, differing from standard peritoneal catheters. Always refer to the product documentation for specific sizing details.
What regulatory pathways were followed for these devices, and how does that impact traceability?
These devices were cleared via FDA 510K (Traditional pathway) and comply with MDD (Medical Device Directive) standards. The regulatory filings include unique registration numbers (e.g., 2527072, 1721676) and product codes (FJS), which enable traceability in medical records and inventory systems. This ensures compliance tracking and simplifies audits for hospitals or home dialysis programs.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180485 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (2)
- FDA 510(k) K180485 24 fields · synced Sep 18, 2026
- EUDAMED 017fa004-cefc-4f84-b794-7aaa50c669a7 61 fields · synced Jul 17, 2026