NWO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Kit, Catheter, Urinary (Exludes Hiv Testing)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- FDA definition
- Urinary Catheterization Kit (Excludes HIV Testing)
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ICATH, STERILESURE (K071496) | Colorado Catheter Company, Inc. | 2007-08-15 | + Add |
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