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Mediport II Model MP-DL Vascular Access Port

FDA 510(k)

Class II (US FDA 510(k))

510(k) K870817

by C. R. Bard, Inc.

Identifiers

510(k) Number
K870817 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 Mediport II Model MP-DL Vascular Access Port is a subcutaneous, implanted, intravascular infusion port and catheter. It is designed as a reservoir system that connects to a long-term intravascular catheter, enabling repeated vascular access for fluid infusion, medication delivery, and blood sampling. This device features a portal body with a resealable septum and outlet, facilitating sterile access to the vascular system.

The device is intended for use in general hospital settings and has received FDA 510(k) clearance under product code LJT via the Traditional pathway. Supplied as a sterile, single-use implant, it requires surgical placement beneath the skin, with the catheter routed intravascularly. Compliance with regulatory standards includes adherence to classification as a Class 2 medical device under FDA regulation 880.5965, with no third-party involvement in its clearance process.

Frequently asked questions

What types of medical procedures is the Mediport II Model MP-DL designed to support, and how does it facilitate repeated access to the vascular system?

The Mediport II Model MP-DL is designed for repeated vascular access in general hospital settings, enabling sterile delivery of fluids, medications, and blood sampling. Its subcutaneous, implanted reservoir system—with a resealable septum—allows healthcare providers to access the vascular system multiple times without repeated needle insertions, reducing patient discomfort and infection risk.

Is the Mediport II Model MP-DL intended for single-use or reusable applications, and how is it supplied?

The Mediport II Model MP-DL is supplied as a sterile, single-use device. It requires surgical implantation beneath the skin, with the catheter routed intravascularly, and is not designed for reuse after initial placement.

What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

The Mediport II Model MP-DL received FDA 510(k) clearance under product code LJT via the Traditional pathway, determined to be substantially equivalent to a predicate device. It is classified as a Class 2 medical device under FDA regulation 21 CFR 880.5965, indicating moderate regulatory oversight.

How is the device intended to be stored before surgical implantation, and are there any special handling requirements?

The Mediport II Model MP-DL is supplied sterile and must be stored in its original packaging until use. Since it is a single-use implant, it should be handled with sterile techniques to prevent contamination before surgical placement. No additional storage conditions (e.g., refrigeration) are specified in the provided data.

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: Mediport Ii Model Mp-dl Vascular Access Port, K870817 - Mediport Ii Model Mp-dl Vascular Access Port, fda.innolitics.com, K864349 FDA 510(k) - MEDIPORT II SINGLE LUM/PORT IMPLANT VAS...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K870817 24 fields · synced Sep 19, 2026