I.V. Start Kit
510(k) K924811
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SEKD | NumberK924811 | Date17 Jun 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SEKD
Overview
AI-generated summary, 6 Oct 2026
The Iv Start Kit is a medical device used for starting intravenous access. It is classified as a General Hospital device with a product code of LRS and a regulation number of 880.5200.
The Iv Start Kit is supplied by Transidyne General Corp. and has been cleared with FDA 510K number K924811. The device is intended for use in a hospital setting and is subject to the regulations and guidelines set forth by the FDA.
Other devices from Transidyne General Corp.
Questions
AI-generated answers, 6 Oct 2026
What is the I.V. Start Kit used for?
The I.V. Start Kit is used for starting intravenous access in a hospital setting, providing a convenient and efficient way to establish IV access for patients.
Is the I.V. Start Kit cleared by the FDA?
Yes, the I.V. Start Kit has been cleared with FDA 510K number K924811, indicating that it has met the necessary regulatory requirements for safety and effectiveness.
What type of device is the I.V. Start Kit classified as?
The I.V. Start Kit is classified as a General Hospital device with a product code of LRS and a regulation number of 880.5200, indicating its intended use in a hospital setting.