Vitalcare Urethral Catheter Red Rubber
by Vitalcare, Inc. 510(k)
Active
510(k) K023872
Overview
This device is a straight urethral catheter made of red rubber, intended for insertion through the urethra to the bladder to facilitate the passage of fluid from the urinary tract. It is classified as a Class II medical device under FDA regulation number 876.5130.
The device was cleared via the FDA 510(k) pathway under submission K023872, with a traditional clearance decision dated April 10, 2003. It is manufactured by Vitalcare, Inc. and is intended for use in clinical settings for urinary drainage, as specified in its intended use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023872 | Date10 Apr 2003 | 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- Withdrawn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
- EZD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vitalcare, Inc.
Questions
What is the Vitalcare Urethral Catheter Red Rubber used for?
It is intended for insertion through the urethra to the bladder to facilitate the passage of fluid from the urinary tract, specifically for urinary drainage in clinical settings as stated in its intended use.
How is the Vitalcare Urethral Catheter Red Rubber supplied and is it sterile?
The device data does not specify sterility or supply format (e.g., single-use, packaged, sterile), so no conclusion can be drawn about its sterility or supply method from the provided information.
What regulatory pathway was used for the Vitalcare Urethral Catheter Red Rubber?
It was cleared via the FDA 510(k) pathway under submission K023872, with a traditional clearance decision dated April 10, 2003, based on a determination of substantial equivalence.