BD Saf-T-Intima Subcutaneous Catheter System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251422 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 Saf-T-Intima Subcutaneous Catheter System is a medical device classified as a subcutaneous catheter designed for vascular access. It provides a secure, low-profile method for administering fluids, medications, or blood products directly beneath the skin, reducing the risk of infection and discomfort compared to traditional intravenous catheters.
This system is intended for single-use in hospital settings and is supplied sterile. It is intended for use in general hospital environments and has been authorized under FDA 510(k) clearance (K251422) and MDR compliance. The device is non-magnetic and suitable for use in MRI environments, though compatibility should be confirmed with MRI equipment specifications. Storage requires protection from extreme temperatures and moisture.
Frequently asked questions
What types of fluids or treatments can the BD Saf-T-Intima™ Subcutaneous Catheter System administer, and why is it preferred over traditional IV catheters?
The BD Saf-T-Intima™ Subcutaneous Catheter System is designed for administering fluids, medications, or blood products directly beneath the skin. It is preferred over traditional intravenous catheters because its low-profile, subcutaneous placement reduces infection risk and discomfort, making it ideal for prolonged or sensitive infusion needs in hospital settings.
Is the BD Saf-T-Intima™ Subcutaneous Catheter System reusable, or is it intended for single-use only? How does this affect its clinical use?
The device is explicitly intended for single-use only in hospital settings, as stated in the manufacturer’s description. This design choice ensures sterility and reduces the risk of contamination or infection between patients, which is critical for maintaining safe clinical practices.
What storage conditions are required for the BD Saf-T-Intima™ Subcutaneous Catheter System, and why are these important?
The system must be stored protected from extreme temperatures and moisture to preserve its integrity and sterility. These conditions are critical because exposure to heat, cold, or humidity could compromise the catheter’s material properties, sterility assurance, or functionality before use.
Can the BD Saf-T-Intima™ Subcutaneous Catheter System be used in MRI environments, and what precautions should be taken?
Yes, the device is non-magnetic and suitable for use in MRI environments, though users should always confirm compatibility with the specific MRI equipment being used. This is because while the catheter itself won’t interfere with magnetic fields, other components (e.g., connectors or accessories) may not be MRI-safe.
How do I know which size or model of the BD Saf-T-Intima™ Subcutaneous Catheter System is appropriate for a patient?
The provided specifications do not list explicit sizes or models, so selection should be based on clinical assessment and manufacturer guidelines (e.g., patient anatomy, infusion requirements). For precise sizing, consult the product labeling or contact Becton Dickinson’s technical support, as improper sizing could lead to complications like dislodgment or tissue damage.
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: Becton Dickinson – Wikipedia, BD (company) - Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251422 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton Dickinson Infusion Therapy Systems Inc.
- FDA Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
Sources (2)
- FDA 510(k) K251422 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026