Lundia 10-3-L Parallel Flow Dialyzer
FDA 510(k)Class II (US FDA 510(k))
by Gambro, Inc.
Identifiers
- 510(k) Number
- K831338 FDA 510(k)
- FDA Product Code
- KOC 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 Lundia 10-3-L Parallel Flow Dialyzer is a medical device classified as an accessory for blood circuit in hemodialysis. It is designed for use in hemodialysis procedures to facilitate the removal of waste and excess fluid from the blood.
The device is manufactured by Gambro, Inc. and received FDA 510(k) clearance with number K831338 on May 27, 1983, as substantially equivalent. It is regulated under product code KOC and regulation number 876.5820, with a medical specialty in gastroenterology and urology.
Frequently asked questions
What is the Lundia 10-3-L Parallel Flow Dialyzer used for?
The Lundia 10-3-L Parallel Flow Dialyzer is designed for use in hemodialysis procedures to facilitate the removal of waste and excess fluid from the blood. It serves as an accessory for the blood circuit in hemodialysis treatments.
Is the Lundia 10-3-L Parallel Flow Dialyster reusable or single-use?
The device data does not specify whether the Lundia 10-3-L Parallel Flow Dialyzer is designed for single-use or reuse. This information would typically be found in the device's instructions for use, which are not provided in the available data.
What regulatory approvals does the Lundia 10-3-L Parallel Flow Dialyzer have?
The Lundia 10-3-L Parallel Flow Dialyzer received FDA 510(k) clearance with number K831338 on May 27, 1983, as substantially equivalent. It is regulated under product code KOC and regulation number 876.5820, with a medical specialty in gastroenterology and urology.
What sizes or models of the Lundia Parallel Flow Dialyzer are available?
The available data only mentions the Lundia 10-3-L Parallel Flow Dialyzer model. No other sizes or models are specified in the provided information. The '10-3-L' designation may refer to specific characteristics, but the exact meaning isn't detailed in the device data.
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: LUNDIA 10-3-L PARALLEL FLOW DIALYZER - Innolitics, K831338 FDA 510 (k) - LUNDIA 10-3-L PARALLEL FLOW DIALYZER, LUNDIA 10-3-L PARALLEL FLOW DIALYZER 510(k) K831338 - FDA.report, PDF K831338 - Lundia 10-3-l Parallel Flow Dialyzer, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831338 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro, Inc.
Sources (1)
- FDA 510(k) K831338 24 fields · synced Sep 22, 2026