Capillary Flow Dialyzers Models Ht. 130 & 170
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K883644 FDA 510(k)
- FDA Product Code
- FJI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Capillary Flow Dialyzers Models HT.130 & HT.170 are Dialyzer, Capillary, Hollow Fiber devices designed for hemodialysis. These devices utilize a semipermeable membrane to filter blood by removing waste products, excess fluids, and electrolytes through the process of diffusion and convection, supporting renal function in patients with acute or chronic kidney failure.
These dialyzers are intended for single-use in clinical settings, including hemodialysis units. Supplied sterile and classified under FDA product code FJI, they are regulated under 21 CFR 876.5820 as Class II devices with special controls. The models HT.130 and HT.170 are differentiated by their specific membrane surface area and filtration characteristics, adhering to FDA clearance K883644 granted in 1988.
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: Capillary Flow Dialyzers Models Ht. 130 & 170, CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 (K883644) - FDA 510 (k ..., CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 - BEUDAMED, Capillary Flow Dialyzers Models Ht. 130 & 170 510(k) K883644 - 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 | K883644 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baxter Healthcare Corp
Sources (1)
- FDA 510(k) K883644 24 fields · synced Oct 6, 2026