Implanted ports

ICU Medical, Inc.

by Icu Medical, Inc.

A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.

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ICU Medical, Inc. models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
21-4437-24Catheter Gauge 6 Fr MR ConditionalAvailable

FDA clearances

  • 510(k) K093414 March 2010

Procedures that use implanted ports

Frequently asked questions

What is ICU Medical, Inc. used for?

A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.

Who makes ICU Medical, Inc.?

ICU Medical, Inc. is made by Icu Medical, Inc.. It is listed under implanted ports (port-a-cath) in our device library.

What sizes does ICU Medical, Inc. come in?

Sizes listed for ICU Medical, Inc.: Catheter Gauge: 6 Fr. Confirm availability with the manufacturer's instructions for use.

Is ICU Medical, Inc. MRI safe?

The FDA device database lists ICU Medical, Inc. as MR Conditional. Always follow the specific MRI conditions in the labeling.

Is ICU Medical, Inc. FDA cleared?

ICU Medical, Inc. is covered by FDA submission K093414.

How do I contact a Icu Medical, Inc. sales representative?

Icu Medical, Inc. has not listed representatives on LA Vascular yet. Visit the Icu Medical, Inc. company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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