Mdc Safe Step Safety I.V. Catheter System
by MDC Research, Ltd. 510(k)
Active
510(k) K960013
Overview
The MDC Safe Step Safety IV Catheter System is a short-term intravascular catheter designed for insertion into the patient’s vascular system. It includes a slender tube and necessary connecting fittings to facilitate blood sampling, blood pressure monitoring, or intravenous administration over periods of less than 30 days. This system is intended for general hospital use and is classified under the product code FOZ. Its design emphasizes safety and ease of insertion for clinical procedures.
The system is supplied as a sterile, single-use device, intended for use in controlled clinical settings such as hospitals. It adheres to FDA 510(k) clearance standards, with a traditional review process under the General Hospital advisory committee. No specific MRI safety information is provided, and the device must be stored under manufacturer-recommended conditions to maintain sterility and functionality. The clearance date is February 13, 1996, under K-number K960013.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK960013 | Date13 Feb 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FOZ
- FDA applicant
- MDC Research , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from MDC Research, Ltd.
Questions
What is the MDC Safe Step Safety IV Catheter System used for?
This system is designed for short-term intravascular use, allowing healthcare professionals to perform blood sampling, monitor blood pressure, or administer intravenous fluids. It is intended for general hospital procedures requiring vascular access for periods of less than 30 days. The catheter’s design prioritizes safety and ease of insertion to minimize complications during clinical use.
Is the MDC Safe Step Safety IV Catheter System sterile and single-use?
Yes, the MDC Safe Step Safety IV Catheter System is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and reduces the risk of infection, making it ideal for controlled clinical settings like hospitals.
How should the MDC Safe Step Safety IV Catheter System be stored?
To maintain sterility and functionality, the device must be stored according to the manufacturer’s recommended conditions. Proper storage ensures the catheter remains intact and ready for use when needed, adhering to best practices for medical device preservation.
What regulatory pathway does the MDC Safe Step Safety IV Catheter System follow?
The system follows the FDA 510(k) clearance pathway, specifically under a traditional review process. It was classified as substantially equivalent to a predicate device and reviewed by the General Hospital advisory committee (HO) before receiving clearance on February 13, 1996, under K-number K960013.
Are there any special considerations for using this catheter near MRI machines?
The manufacturer does not provide specific MRI safety information for the MDC Safe Step Safety IV Catheter System. Clinicians should follow standard MRI safety protocols and consult the device documentation or manufacturer guidelines before use in an MRI environment to avoid potential risks.