# K903364: Gerard Medical, Inc. Trim-Port

- Pathway: 510(k) (Traditional)
- Applicant: Gerard Medical Enterprises, Inc.
- Decided: Oct 31, 1990 after 97 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 8 (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. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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.
- Jul 22, 2005 · Not classified · Z-1479-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

Source page: https://510kreport.com/device/K903364
Methodology: https://510kreport.com/methodology