MNI 400 Injection Caps
510(k) K852162
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852162 | Date12 Jun 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LFJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MNI 400 Injection Caps are a type of catheter accessory designed for use with subclavian catheters. These caps provide a sterile barrier to prevent contamination during injections or infusions, ensuring safe access to the catheter lumen while maintaining aseptic conditions. They are classified as a catheter accessory under FDA regulations and are intended for use in medical settings requiring controlled blood access procedures.
These injection caps are supplied sterile and intended for single-use to minimize infection risk. They are compatible with subclavian catheters and are regulated under FDA 510(k) clearance (K852162) as substantially equivalent to predicate devices. Storage requires adherence to sterile packaging guidelines, and their use is governed by regulatory standards for blood access devices in gastroenterology and urology applications. No MRI safety information is provided, and sizes or additional specifications beyond the product name are not detailed in the regulatory data.
Other devices from Med-West, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the MNI 400 Injection Caps used for?
The MNI 400 Injection Caps are designed as catheter accessories specifically for subclavian catheters. They create a sterile barrier during injections or infusions, reducing contamination risk and maintaining aseptic conditions in medical procedures. This is particularly important in specialties like gastroenterology and urology, where controlled blood access is critical.
Are the MNI 400 Injection Caps sterile and for single-use?
Yes, the MNI 400 Injection Caps are supplied sterile and intended for single-use only. Single-use minimizes the risk of infection by preventing reuse, which could introduce pathogens into the catheter lumen. This aligns with best practices for maintaining sterile environments in medical settings.
How should the MNI 400 Injection Caps be stored?
The MNI 400 Injection Caps must be stored according to sterile packaging guidelines to preserve their sterility. This includes keeping them in their original, unopened packaging and avoiding exposure to moisture, heat, or contamination. Proper storage ensures the caps remain effective for their intended use.
Are there any specific sizes or additional specifications for the MNI 400 Injection Caps?
The regulatory data for the MNI 400 Injection Caps does not provide detailed specifications beyond the product name, such as sizes or dimensions. However, they are designed to be compatible with subclavian catheters and function as a universal accessory for this type of device. Always verify compatibility with your specific catheter model before use.
What regulatory approval does the MNI 400 Injection Caps hold?
The MNI 400 Injection Caps are cleared under the FDA’s 510(k) program, specifically with clearance number K852162. This clearance categorizes them as substantially equivalent to predicate devices, meaning they meet FDA standards for safety and effectiveness as catheter accessories. The device is classified under product code LFJ and falls under FDA regulation 876.5540.