CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K970663 FDA 510(k)
- FDA Product Code
- MSF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5860 FDA 510(k)
- Regulation Number
- 876.5860 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G) is a Hemodialyzer, Re-Use, High Flux designed for blood purification in renal replacement therapy. It employs triacetate cellulose hollow fiber membranes to facilitate efficient dialysis by filtering waste products and excess fluids from the bloodstream during hemodialysis sessions. The device is engineered to support high-flux dialysis, which enhances the removal of middle molecules and solutes compared to conventional hemodialysis systems.
This dialyzer is intended for multiple-use and undergoes gamma sterilization before first use. It is classified under FDA regulation 876.5860 and is supplied as a reusable medical device for clinical settings, including nephrology units. The device is available in two configurations, CT-110G and CT-190G, with specifications tailored for compatibility with standard hemodialysis machines. No additional regulatory approvals beyond the FDA 510(k) clearance (K970663) are stated in the provided data.
Frequently asked questions
What is the CT Celluloser Triacetate Dialyzer (CT-110G/CT-190G) used for?
This device is designed for hemodialysis, a form of renal replacement therapy. It filters waste products and excess fluids from the bloodstream during dialysis sessions. The triacetate cellulose hollow fiber membranes enhance the removal of middle molecules and solutes, making it particularly effective for high-flux dialysis compared to standard hemodialysis systems.
How is the CT Celluloser Triacetate Dialyzer supplied and prepared for use?
The dialyzer is supplied as a reusable medical device, gamma-sterilized before its first use. It is intended for clinical settings, including nephrology units, and must be processed and maintained according to manufacturer guidelines to ensure safety and efficacy for multiple reuse cycles.
Is the CT Celluloser Triacetate Dialyzer single-use or reusable?
This dialyzer is explicitly designed for multiple-use. It undergoes gamma sterilization prior to first use, allowing it to be reused after proper cleaning and reprocessing, as outlined in Baxter Healthcare’s instructions for use.
What are the key differences between the CT-110G and CT-190G models?
The CT-110G and CT-190G are two configurations of the same dialyzer, tailored for compatibility with standard hemodialysis machines. While the exact specifications (such as membrane surface area or blood flow capacity) are not detailed here, the models are differentiated to meet varying clinical needs within high-flux hemodialysis protocols.
How should the CT Celluloser Triacetate Dialyzer be stored before first use?
The dialyzer should be stored in its original, sealed packaging in a clean, dry environment at room temperature, protected from direct sunlight and moisture. Gamma sterilization ensures sterility before first use, so the packaging must remain intact until immediate use to maintain sterility.
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: Ct Celluloser Triacetate Hollow Fiber Dialyzer (Ct-110g/Ct-190g ..., CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) 510 (k ..., PDF K970663 - Ct Celluloser Triacetate Hollow Fiber Dialyzer (Ct-110g/Ct-190g), fda.innolitics.com, Promoting Management and Leadership - HealthManagement.org
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970663 | Class II | Active |
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Manufacturer
- Manufacturer
- Baxter Healthcare Corp
Sources (1)
- FDA 510(k) K970663 24 fields · synced Oct 5, 2026