Vygon Split Cannula Introducer
FDA 510(k)Class II (US FDA 510(k))
by Vygon Corp.
Identifiers
- 510(k) Number
- K010913 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vygon Split Cannula Introducer is a catheter introducer, a sheath used to facilitate placement of a catheter through the skin into a vein or artery. It incorporates a split cannula design that enables smooth and controlled catheter insertion while minimizing vessel trauma.
The device is supplied as a single component intended to aid catheter placement in vascular procedures. It is classified under product code DYB as a Class II device with special controls and received FDA 510(k) clearance (K010913) on September 28, 2001.
Frequently asked questions
What is the Vygon Split Cannula Introducer used for?
The Vygon Split Cannula Introducer is used to aid in the placement of a catheter through the skin into a vein or artery during vascular procedures, minimizing vessel trauma.
Is the Vygon Split Cannula Introducer supplied sterile?
The description does not explicitly state that the device is supplied sterile, but it is intended for use in vascular procedures, suggesting it would be provided in a sterile condition.
What is the regulatory status of the Vygon Split Cannula Introducer?
The Vygon Split Cannula Introducer received FDA 510(k) clearance (K010913) on September 28, 2001, indicating it is substantially equivalent to a predicate device.
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: Vygon Split Cannula Introducer - Vygon | FDA Reference, K010913 - VYGON SPLIT CANNULA INTRODUCER | FDA 510(k), VYGON SPLIT CANNULA INTRODUCER by VYGON CORP. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010913 | Class II | Active |
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Manufacturer
- Manufacturer
- Vygon Corp.
Sources (1)
- FDA 510(k) K010913 24 fields · synced Sep 23, 2026