# K954258: Trimport Implantable Access System (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Gerard Medical Enterprises, Inc.
- Decided: May 24, 1996 after 262 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ideas' Port: named in the summary without a submission number
- (no number) LifePort with PolyCath Catheter: named in the summary without a submission number

## Recalls of this device
- May 13, 2010 · Not classified · Z-1883-2010: 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.
- May 13, 2010 · Not classified · Z-1882-2010: 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.
- May 13, 2010 · Not classified · Z-1886-2010: 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.
- May 13, 2010 · Not classified · Z-1881-2010: 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.
- May 13, 2010 · Not classified · Z-1887-2010: 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.
- May 13, 2010 · Not classified · Z-1884-2010: 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.
- May 13, 2010 · Not classified · Z-1885-2010: 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.
- Jun 13, 2006 · Not classified · Z-0745-2007: Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by supplier B. Braun Medical of the error)
- Jun 13, 2006 · Not classified · Z-0746-2007: Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error)
- Oct 28, 2005 · Not classified · Z-0340-06: Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
- Jul 22, 2005 · Not classified · Z-1481-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1476-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

## Indications for use
The Gerard Medical, Inc. TrimPort Implantable Access System is precision engineered to provide repeated access to the vascular system for both parenteral delivery of fluids and the withdrawal of venous blood.

Source page: https://510kreport.com/device/K954258
Methodology: https://510kreport.com/methodology