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Powerport(tm)implanted Titanium Port W/8 Fr. Chronoflex Catheter-Multiple

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060812

by C. R. Bard, Inc.

Identifiers

510(k) Number
K060812 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 PowerPort Implanted Titanium Port with 8 Fr. Chronoflex Catheter is a subcutaneous, implanted vascular access device classified as a Port & Catheter (Implanted, Subcutaneous, Intravascular). Constructed with a titanium housing and a Chronoflex catheter, it is designed for repeated vascular access in general hospital settings. This device facilitates infusion of medications, intravenous fluids, parenteral nutrition, blood products, and blood withdrawal.

Supplied sterile for single-use, this device is intended for implantation by healthcare professionals. It is regulated under FDA 510(k) clearance (K060812) and classified as a Class II device with special controls. The titanium port and Chronoflex catheter are intended for subcutaneous and intravascular use, respectively. Proper storage and handling are required to maintain sterility and functionality.

PowerPort Implanted Titanium Port with 8 Fr. Chronoflex Catheter

Frequently asked questions

What is the PowerPort Implanted Titanium Port with 8 Fr. Chronoflex Catheter used for?

This device is designed for repeated vascular access in general hospital settings. It allows healthcare professionals to administer medications, intravenous fluids, parenteral nutrition, blood products, and perform blood withdrawals through a subcutaneous (under-the-skin) implanted port and an intravascular catheter.

How is the PowerPort Titanium Port supplied and intended for use?

The PowerPort Titanium Port with 8 Fr. Chronoflex Catheter is supplied sterile and intended for single-use only. It must be implanted by trained healthcare professionals in a clinical setting to ensure proper placement and functionality.

Is the PowerPort Titanium Port reusable or single-use?

This device is explicitly designed for single-use only. After implantation and use, it should not be reused to maintain sterility and prevent infection risks.

What materials are used in the construction of this port and catheter?

The PowerPort Titanium Port features a titanium housing, which is durable and biocompatible, while the catheter is made from Chronoflex—a flexible, long-lasting material designed for intravascular use.

How should the PowerPort Titanium Port be stored to maintain sterility?

The device must be stored in its original, unopened packaging until ready for use. Proper storage conditions, as specified by the manufacturer, should be followed to preserve sterility and functionality before implantation.

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: Powerport (Tm)Implanted Titanium Port W/8 Fr. Chronoflex Catheter ..., K060812 FDA 510(k) - POWERPORT(TM)IMPLANTED TITANIUM PORT W/..., Powerport(Tm)Implanted Titanium Port W/8 Fr. Chronoflex Catheter ..., PDF POWERPORT (TM)IMPLANTED TITANIUM PORT W/8 FR… - FDA.report

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) K060812 24 fields · synced Oct 1, 2026