BD Cathena Safety IV Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172506 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 BD Cathena Safety IV Catheter is a peripheral intravenous catheter designed for short-term vascular access. It is intended for blood sampling, blood pressure monitoring, or fluid administration via the peripheral venous system, featuring a winged design for enhanced stability during insertion.
Supplied sterile and intended for single-use, this catheter incorporates Blood Control technology to reduce blood exposure risk and provide immediate visual confirmation of vessel entry. The device is regulated under FDA 510(k) clearance (K172506) and is classified under product code FOZ. It is not MRI-safe and must be stored in a clean, dry environment as per manufacturer guidelines.
Frequently asked questions
What is the primary purpose of the BD Cathena Safety IV Catheter, and how does its winged design benefit the user?
The BD Cathena Safety IV Catheter is designed for short-term peripheral intravenous access to administer fluids, monitor blood pressure, or draw blood samples. Its winged design provides enhanced stability during insertion, making it easier to secure the catheter in place once inserted, which reduces the risk of dislodgment and improves patient comfort.
How does the Blood Control technology in this catheter reduce the risk of blood exposure during use?
The Blood Control technology in the BD Cathena Safety IV Catheter is engineered to minimize blood exposure by ensuring immediate visual confirmation of vessel entry. This feature helps prevent accidental needle sticks or spills, which can occur during insertion or removal, thereby lowering the risk of bloodborne pathogen exposure for healthcare providers.
Is this catheter reusable, or is it intended for single-use only? How should it be stored to maintain sterility?
The BD Cathena Safety IV Catheter is intended for single-use only and is supplied sterile. To preserve sterility, it must be stored in a clean, dry environment as specified by the manufacturer. Avoid exposure to moisture, extreme temperatures, or contamination before use.
Can this catheter be used in an MRI setting, or are there any special handling requirements?
The BD Cathena Safety IV Catheter is not MRI-safe, meaning it should not be used in an MRI environment. If MRI procedures are required for the patient, the catheter must be removed beforehand, and a non-ferromagnetic alternative should be considered for subsequent procedures.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in hospitals?
The BD Cathena Safety IV Catheter received FDA clearance through a 510(k) Traditional review process (K172506) and is classified under product code FOZ, which falls under the General Hospital category. This clearance indicates the device was determined to be substantially equivalent to a legally marketed predicate device, meaning it meets established safety and effectiveness standards for short-term peripheral IV use in hospital settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD Cathena™ Safety IV Catheter with BD Multiguard™ Technology, Cathena™ Safety IV Catheters with Blood Control - Bound Tree, BD (company) - Wikipedia, BD Cathena™ Safety IV Catheter 386883
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172506 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K172506 24 fields · synced Oct 6, 2026