Terumo Surflo Flex I.v. Catheter And Terumo Surflash I.v. Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K991406 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Terumo Surflo Flex I.V. Catheter and Terumo SurfFlash I.V. Catheter are intravascular catheters designed for peripheral intravenous access. They feature a double-bevel introducer needle and a polyurethane construction, providing flexibility, kink resistance, and ease of insertion for reliable vascular access.
These catheters are supplied sterile and intended for single-use. They are classified under product code FOZ and are approved for use in general hospital settings. The SurfFlash model includes a clear preview chamber in the hub for visual confirmation of needle placement, while both models adhere to FDA 510(k) clearance 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: Terumo.com | TERUMO GLOBAL, SurFlash® Polyurethane I.V. Catheters - terumotmp.com, Terumo – Wikipedia, IV Catheters - terumotmp.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991406 | Class II | Active |
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Manufacturer
- Manufacturer
- Terumo Medical Corp.
Sources (1)
- FDA 510(k) K991406 24 fields · synced Oct 6, 2026