Central Vein Catherization Kit
510(k) K823758
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823758 | Date23 Feb 1983 | 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- Withdrawn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
- DQO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a catheter, intravascular, diagnostic (Product Code: DQO) designed for central vein catheterization. It comprises components used to insert and secure a catheter within a central vein, facilitating venous access for therapeutic or diagnostic procedures. The kit includes sterile instruments and supplies necessary for safe and accurate placement, such as catheters, dilators, introducers, and sterile drapes. Its primary function aligns with cardiovascular applications, supporting fluid administration, blood sampling, or monitoring of central venous pressure.
The Central Vein Catheterization Kit is intended for single-use in clinical settings such as hospitals or procedural rooms. It is supplied sterile and requires aseptic technique during use. The kit is classified under 870.1200 and has received FDA 510(k) clearance (K823758) as substantially equivalent (SESE) to a predicate device. No additional regulatory markings or MRI safety classifications are specified in the data. Storage should follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Access Devices, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Central Vein Catheterization Kit used for?
This kit is designed for central vein catheterization, providing venous access for therapeutic or diagnostic procedures. It supports fluid administration, blood sampling, or monitoring of central venous pressure in cardiovascular applications. The components—catheters, dilators, introducers, and sterile drapes—ensure safe and accurate placement under aseptic conditions.
Is the Central Vein Catheterization Kit sterile and single-use?
Yes, the kit is supplied sterile and intended for single-use only. Sterility is critical for preventing infection during catheterization, and the manufacturer’s guidelines must be followed to maintain sterility before and during use.
What components are included in the Central Vein Catheterization Kit?
The kit includes sterile catheters, dilators, introducers, and sterile drapes. These components work together to facilitate the insertion and secure placement of the catheter within a central vein, ensuring proper access for medical procedures.
How should the Central Vein Catheterization Kit be stored?
Storage must follow the manufacturer’s instructions to preserve sterility and functionality. Typically, this involves keeping the kit in its original packaging, sealed and protected from contamination, until immediate use. Avoid exposure to moisture, extreme temperatures, or direct sunlight.
What regulatory approval does the Central Vein Catheterization Kit hold?
The kit has received FDA 510(k) clearance (K823758) as substantially equivalent (SESE) to a predicate device. This classification confirms it meets regulatory standards for safety and effectiveness as an intravascular diagnostic catheter (Product Code: DQO). No additional regulatory markings or MRI safety classifications are specified.