Acute Central Venous Access Catheter Tray
by Neostar Medical Technologies, Inc.
510(k) K944660
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944660 | Date13 Mar 1995 | 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- Withdrawn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
- FOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Central Venous Catheter Tray designed for acute medical use. It provides a sterile, pre-packaged assembly of components required for the insertion and securement of a central venous catheter, including catheters, introducers, dressings, and fixation devices. The tray facilitates rapid and aseptic catheter placement in clinical settings such as intensive care units or emergency departments, where quick vascular access is critical. Its configuration minimizes contamination risk during procedural setup.
The Acute Central Venous Access Catheter Tray is intended for single-use in sterile environments and is supplied as a pre-sterilized, ready-to-use assembly. It adheres to 21 CFR 880.5200 under the FDA’s 510(k) clearance (K944660) and is classified under product code FOZ for general hospital use. Storage requires protection from moisture and physical damage, and it must remain unopened until immediate clinical use. No MRI safety labeling or reusable components are indicated in the specifications.
Other devices from Neostar Medical Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Acute Central Venous Access Catheter Tray used for?
The Acute Central Venous Access Catheter Tray is designed for acute medical use to facilitate the insertion and securement of central venous catheters in clinical settings like intensive care units or emergency departments. Its pre-packaged, sterile assembly reduces contamination risk during setup, ensuring quick and safe vascular access when time is critical.
How is the Acute Central Venous Access Catheter Tray supplied?
The tray is supplied as a pre-sterilized, ready-to-use assembly in a single-use configuration. It includes all necessary components—catheters, introducers, dressings, and fixation devices—packaged together to streamline the insertion process without requiring additional preparation.
Is the tray reusable or intended for single-use?
The Acute Central Venous Access Catheter Tray is explicitly designed for single-use only. It is pre-sterilized and intended to be used once in a sterile environment before disposal. Reuse is not recommended or supported by the manufacturer.
What storage requirements does the tray have?
The tray must be stored in a way that protects it from moisture and physical damage. It should remain unopened until immediate clinical use to maintain sterility. Proper storage ensures the integrity of the components until deployment.
Does the tray include any reusable components?
No reusable components are included in the Acute Central Venous Access Catheter Tray. The entire assembly—catheters, introducers, dressings, and fixation devices—is intended for single-use only, adhering to sterile medical practice standards.