Mentor Self-Cath Hydrogel Intermittent Catheter
by Mentor Corp. 510(k)
Active
510(k) K050008
Overview
This device is a straight intermittent urinary catheter made of flexible medical grade PVC with a hydrogel coating and smooth fire-polished eyelets. It is intended for bladder drainage in male, female, and pediatric patients as determined by a physician.
It is supplied sterile for single-use and is latex-free. The device is classified as a Class II medical device under FDA regulation number 876.5130 with product code EZD, and has received FDA 510(k) clearance (K050008).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050008 | Date3 Jun 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EZD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Mentor Corp.
Questions
What is the MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER used for?
It is intended for bladder drainage in male, female, and pediatric patients as determined by a physician, providing a sterile, single-use solution for intermittent catheterization.
How is the MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER supplied and is it sterile?
The device is supplied sterile for single-use, ensuring it is free from microorganisms at the point of use and designed to be discarded after one application to prevent infection risk.
What materials is the MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER made of and does it contain latex?
It is made of flexible medical grade PVC with a hydrogel coating and smooth fire-polished eyelets, and is explicitly latex-free, reducing the risk of allergic reactions in sensitive patients.