3M IV Flow Regulator
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K896907 FDA 510(k)
- FDA Product Code
- LDR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 3M IV Flow Regulator is an electronic, intravascular infusion controller. It is designed to regulate the flow of intravenous fluids to a patient.
This device is regulated as a Class II medical device under product code LDR. It received FDA 510(k) clearance on February 26, 1990, under K896907.
Frequently asked questions
What is the primary function of the 3M IV Flow Regulator?
The 3M IV Flow Regulator is an electronic, intravascular infusion controller. Its primary purpose is to regulate the flow of intravenous fluids being administered to a patient.
How is this device classified for regulatory purposes?
This device is regulated as a Class II medical device under product code LDR. It received FDA 510(k) clearance on February 26, 1990, under K number K896907.
Which medical specialty committee oversees this device?
The 3M IV Flow Regulator falls under the oversight of the General Hospital advisory committee, which reviews devices categorized for use in general hospital settings.
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: K896907 FDA 510(k) - 3M IV FLOW REGULATOR | 3M Company, 3M IV FLOW REGULATOR (K896907) — FDA 510(k) | Innolitics, PDF K896907 3M IV FLOW REGULATOR - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896907 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K896907 24 fields · synced Sep 27, 2026