Port-Gard

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K854019 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Cormed II Ambulatory Infusion Pump

  Class II

  FDA 510(k) K850674 Active Cleared 9 Apr 1985

• Sterile Cormed Mediport

  Class II

  FDA 510(k) K850967 Active Cleared 17 May 1985

• Butterfly Non-Coring Needle Set

  Class II

  FDA 510(k) K863606 Active Cleared 18 Dec 1986

• Corcath H & B Vascular Access Catheter

  Class II

  FDA 510(k) K823553 Active Cleared 5 Jan 1983

• Cormed Huber Point Needle

  Class I

  FDA 510(k) K843083 Active Cleared 5 Sep 1984

• Percutaneous Introducer Kit

  Class II

  FDA 510(k) K860432 Active Cleared 31 Mar 1986

See all devices from Cormed, Inc., Sub. C.R.Bard, Inc. →

• What types of medical procedures or treatments is the Port-Gard designed to support, and how does it differ from other intravenous access methods?

  The Port-Gard is specifically designed for long-term intravenous access, allowing for the administration of medications, fluids, or blood products, as well as venous sampling. Unlike traditional catheters that may require frequent insertion or dressing changes, the Port-Gard is implanted under the skin, providing a more stable and durable access point. This makes it ideal for patients requiring repeated or prolonged treatments, such as chemotherapy, antibiotic therapy, or parenteral nutrition, where frequent needle sticks to peripheral veins can be painful or impractical.

• Is the Port-Gard compatible with MRI scans, and if so, what precautions should be taken?

  Yes, the Port-Gard is compatible with MRI environments, but only when non-ferromagnetic materials are confirmed. Before an MRI procedure, it’s critical to verify that the implanted components do not contain metallic parts that could interfere with the scan or pose a safety risk. Always consult the manufacturer’s guidelines and the MRI facility’s protocols to ensure safe imaging.

• How is the Port-Gard supplied, and what should be considered regarding its sterility and single-use nature?

  The Port-Gard is supplied sterile in its packaging, ensuring it meets clinical standards for aseptic procedures. It is intended for single-use only, meaning each implanted system should not be reused. This design minimizes infection risks and ensures patient safety, as reuse could compromise sterility and integrity. Always follow the sterile packaging instructions provided by the manufacturer for proper handling and preparation.

• What catheter lengths and configurations are available for the Port-Gard, and how might this affect its clinical application?

  The Port-Gard is available in multiple catheter lengths and configurations, each identified by unique FEI numbers (e.g., 1000523114, 3004407880, etc.). These variations allow clinicians to select the appropriate length and routing based on the patient’s anatomy and intended use—such as targeting specific veins or adjusting for body size. For example, shorter catheters may be preferred for pediatric patients, while longer ones might be needed for adults requiring deeper venous access.

• What storage requirements should be followed to maintain the Port-Gard’s sterility and functionality before implantation?

  The Port-Gard must be stored strictly according to the manufacturer’s sterile packaging instructions to preserve its integrity. This includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by ensuring the packaging remains intact until immediate use, as any breach could compromise sterility and render the device unsafe for implantation.