Trimport

• 7 recalls, same reason

  • Terminated Z-1882-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1886-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1885-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1887-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1881-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1883-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010
  • Terminated Z-1884-2010 FDA Unclassified (pre-2012) ·initiated 13 May 2010

  FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.

510(k) Number

K945250 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Dual Plastic Vascular Access System

  Class II

  FDA 510(k) K922147 Active Cleared 4 Dec 1992

• Gerard Medical, Inc. Trim-Port

  Class II

  FDA 510(k) K903364 Active Cleared 31 Oct 1990

• Modified Version Implantable Vascular Access Syste

  Class II

  FDA 510(k) K912111 Active Cleared 8 Oct 1991

• Trimport

  Class II

  FDA 510(k) K942623 Active Cleared 23 Aug 1994

• Trim-Port(Tm) Implant Access Syst Dual Titan Port

  Class II

  FDA 510(k) K913114 Active Cleared 2 Jan 1992

• Gerard Medical Electrode Tester

  Class II

  FDA 510(k) K813358 Active Cleared 29 Dec 1981

See all devices from Gerard Medical Enterprises, Inc. →

• What is the TrimPort Implantable Access System used for?

  The TrimPort Implantable Access System is designed for repeated intravascular access, enabling the parenteral administration of fluids and blood withdrawal. It serves as a long-term solution for patients requiring frequent intravenous therapies or blood sampling, providing reliable and convenient access without repeated needle insertions.

• Is the TrimPort supplied sterile and intended for single-use?

  Yes, the TrimPort is supplied sterile and is intended for single-use implantation. This ensures patient safety by minimizing the risk of infection and contamination associated with reusable devices.

• What type of medical facility is the TrimPort intended for?

  The TrimPort is classified under product code LJT and is intended for use in general hospital settings. Its design and regulatory compliance align with standards for devices used in clinical environments requiring sterile, long-term vascular access.

• Does the TrimPort have any MRI safety information?

  The provided data does not include any specific MRI safety information for the TrimPort Implantable Access System. Patients or clinicians should consult the manufacturer’s instructions or additional documentation for MRI-related precautions before use.

• What regulatory pathway does the TrimPort follow?

  The TrimPort Implantable Access System follows the FDA 510(k) clearance pathway, specifically classified as substantially equivalent to a predicate device under the FDA’s regulations. It holds clearance number K945250 and adheres to regulatory requirements outlined under 880.5965.