Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage Adaptor, Model CDA1000
510(k) K033830
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033830 | Date9 Jan 2004 | 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- Withdrawn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
- EZL
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a catheter, retention type, balloon, designed for urinary bladder drainage. It features a balloon mechanism to secure placement within the bladder, ensuring stability during use. The Option-VF Urinary Catheter with Adaptor is paired with a continuous drainage adaptor to facilitate fluid evacuation, reducing the risk of urinary retention or obstruction.
The Option-VF Urinary Catheter with Adaptor (Model FVA14218) and the Option-V Continuous Drainage Adaptor (Model CDA1000) are intended for single-use in clinical settings such as hospitals or outpatient care. Supplied sterile, these components are classified under FDA regulation 876.5130 and hold a 510(k) clearance for substantial equivalence. The device is intended for female patients requiring short-term (14 days or less) urinary management, with no MRI safety considerations specified.