Identifiers
- 510(k) Number
- K013287 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nipro Safelet Cath is a medical device designed for general hospitals, providing a reliable and effective solution for short-term intravascular therapeutic procedures. With its third-party flag indicating regulatory compliance and an expedited review flag suggesting streamlined clearance processes, this device offers increased confidence in its performance.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013287 | Class II | Active |
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Manufacturer
- Manufacturer
- Nipro Medical Corp.
Sources (1)
- FDA 510(k) K013287 24 fields · synced Jul 24, 2026