Vascular Solutions Sclero-Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043019 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vascular Solutions Sclero-Kit is a sterile, disposable procedural kit containing a 10ml syringe, 3ml syringe with needle, butterfly needle, extension tubing, and syringe connector. It is used for the delivery of sclerosing agents to treat small, uncomplicated lower extremity varicosities with competent valves.
The kit is supplied with standard medical devices bundled for user convenience. It has received FDA 510(k) clearance, indicated by the authorization number K043019. The kit is intended for single-use and is designed for use by clinicians in a medical setting.
Frequently asked questions
What is the Sclero-Kit used for?
The Sclero-Kit is used for the delivery of sclerosing agents to treat small, uncomplicated lower extremity varicosities with competent valves, providing a convenient and sterile solution for clinicians.
Is the Sclero-Kit sterile and disposable?
Yes, the Sclero-Kit is supplied as a sterile, disposable procedural kit, intended for single-use in a medical setting to ensure patient safety and convenience.
What devices are included in the Sclero-Kit?
The kit contains a 10ml syringe, 3ml syringe with needle, butterfly needle, extension tubing, and syringe connector, providing a comprehensive set of devices for sclerosing agent delivery.
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: VASCULAR SOLUTIONS SCLERO-KIT (K043019) — FDA 510 (k) | Innolitics, K043019 - VASCULAR SOLUTIONS SCLERO-KIT | FDA 510 (k), PDF K043019 - Vascular Solutions Sclero-kit, Vascular Solutions - Now part of Teleflex | LinkedIn
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043019 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA 510(k) K043019 24 fields · synced Sep 25, 2026