Celsite Implantable Access Port Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130576 FDA 510(k)
- FDA Product Code
- LJT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5965 FDA 510(k)
- Regulation Number
- 880.5965 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Celsite Implantable Access Port Systems are subcutaneous, implanted vascular access devices designed for repeated intravenous access. Classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular, these systems facilitate long-term venous infusion, blood sampling, and transfusion therapies.
These systems are intended for single-use and require surgical implantation beneath the skin, with a catheter connected to a central vein. Supplied sterile and regulated under FDA 510(k) clearance (K130576), they are categorized as Class II medical devices. Proper storage and handling per manufacturer instructions are required to maintain sterility and functionality.
Frequently asked questions
What is the primary purpose of the Celsite Implantable Access Port Systems and how does it differ from other vascular access methods?
The Celsite Implantable Access Port Systems are designed for repeated intravenous access, allowing long-term venous infusion, blood sampling, and transfusion therapies. Unlike traditional peripheral IVs or short-term catheters, these devices are subcutaneously implanted, providing a more stable and durable access point for patients requiring frequent or prolonged treatments. The system includes a catheter connected to a central vein, reducing the need for repeated needle insertions into peripheral veins.
Are the Celsite Implantable Access Port Systems reusable or intended for single-use, and what does this mean for clinical workflow?
The Celsite Implantable Access Port Systems are intended for single-use after surgical implantation. This means each device is designed for one patient and should not be reused, ensuring sterility and minimizing infection risks. Clinically, this requires proper disposal after use and may influence inventory management, as replacements must be available for patients requiring long-term access.
What storage and handling precautions must be taken to maintain sterility and functionality before implantation?
The Celsite Implantable Access Port Systems are supplied sterile, so they must be stored and handled according to the manufacturer’s instructions to preserve sterility and functionality. This typically includes keeping them in their sealed packaging, away from direct sunlight or extreme temperatures, and ensuring the sterile barrier remains intact until use. Improper storage could compromise the device’s integrity before implantation.
What regulatory pathway does the Celsite Implantable Access Port Systems follow, and how does this affect its use in clinical settings?
The Celsite Implantable Access Port Systems are regulated under FDA 510(k) clearance (K130576), classified as a Class II medical device. This clearance indicates the device has been deemed substantially equivalent to a legally marketed predicate, ensuring it meets safety and effectiveness standards. Clinically, this means the device adheres to established regulatory guidelines, but healthcare providers should still follow facility protocols and manufacturer instructions for proper use.
Does the Celsite Implantable Access Port Systems come in multiple sizes or models, and how might this affect patient selection?
The Celsite Implantable Access Port Systems are available in multiple sizes and models, as indicated by the diverse registration numbers (e.g., 1000523114, 3004407880, etc.). These variations likely accommodate different patient anatomies, catheter lengths, or port sizes to optimize comfort and functionality. Clinicians should select the appropriate size based on the patient’s venous access needs, body size, and specific therapeutic requirements to ensure proper placement and performance.
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: Celsite® Access Ports - bisusa.com, Celsite® Implantofix® - B. Braun, Celsite® Epoxy - B. Braun
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130576 | Class II | Active |
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Manufacturer
- Manufacturer
- B Braun Interventional Systems, Inc
- FDA Applicant
- B. Braun Interventional Systems, Inc.
Sources (1)
- FDA 510(k) K130576 24 fields · synced Sep 19, 2026