Symetrex Long Term Hemodialysis Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140884 FDA 510(k)
- FDA Product Code
- MSD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5540 FDA 510(k)
- Regulation Number
- 876.5540 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
The Symetrex Long Term Hemodialysis Catheter is a dual-lumen, implanted catheter designed for chronic hemodialysis and apheresis procedures. It features a symmetric tip and is classified as a hemodialysis catheter under nomenclature authority standards, intended for long-term vascular access.
This device is supplied as a reusable, radiopaque polyurethane catheter with a polyester retention cuff and two female luer adapters. It is available in a 15.5 French size and may be implanted via percutaneous or cut-down methods, with variants exceeding 37 cm implant length intended for femoral placement. Regulated under FDA 510(k) clearance (K140884) and classified as a Class II device under product code MSD.
Frequently asked questions
Is the Symetrex Long Term Hemodialysis Catheter designed for single-use or can it be reused?
The Symetrex Long Term Hemodialysis Catheter is explicitly described as a reusable device. It is made of polyurethane and includes features like a polyester retention cuff, which are typical for long-term implantation and reuse in hemodialysis patients. Always follow manufacturer guidelines and infection control protocols when reusing medical devices.
What are the available sizes and implant lengths for the Symetrex Long Term Hemodialysis Catheter, and how is it typically placed?
The Symetrex Long Term Hemodialysis Catheter is available in a 15.5 French size and comes in variants exceeding 37 cm in implant length, which are specifically intended for femoral placement. It can be implanted via either percutaneous or cut-down methods, depending on clinical preference and patient anatomy.
How is the Symetrex Long Term Hemodialysis Catheter supplied, and what materials are used in its construction?
The catheter is supplied as a radiopaque polyurethane device with a polyester retention cuff and two female luer adapters. The radiopacity ensures visibility under X-ray imaging, which is critical for proper placement and monitoring during hemodialysis procedures.
What regulatory pathway was followed for FDA clearance of the Symetrex Long Term Hemodialysis Catheter, and what classification does it hold?
The Symetrex Long Term Hemodialysis Catheter received FDA 510(k) clearance under the traditional review pathway (K140884) and is classified as a Class II device under product code MSD. This classification aligns with its use as an implanted hemodialysis catheter, subject to specific performance standards.
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: Symetrex Long Term Hemodialysis Catheter - Phase One Medical | FDA ..., SYMETREX LONG TERM HEMODIALYSIS CATHETER (K140884) — FDA 510 (k ..., DeviceMD - SYMETREX™ LONG TERM HEMODIALYSIS CATHETER, PDF SYMETREX /SYMETREX WITH SIDEHOLES Indications for Use - Medcomp
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140884 | Class II | Active |
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Manufacturer
- Manufacturer
- Phase One Medical
Sources (1)
- FDA 510(k) K140884 24 fields · synced Oct 6, 2026