Kit, Catheter, Urinary (Exludes Hiv Testing)
FDA product code NWO · Class II (moderate risk) · 21 CFR 876.5130 · Gastroenterology, Urology
Urinary Catheterization Kit (Excludes HIV Testing)
1510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071496 | Icath, SterilesureNWO · Traditional | Colorado Catheter Company, Inc. | 08/15/2007SESK |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1459-2016 Class II | Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-2656-2015 Class II | URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-0244-2015 Class I | Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |