# K021580: Optilock Implantable Access Port, Models #1700-01, 1700-02, 1700-03, 1700-04 and 1700-05

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Feb 12, 2003 after 274 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The OptiLock Implantable Port is designed for patients who require repeated long term access to the vascular system for intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. The OptiLock Introducer Kit is designed to assist in obtaining access to the vascular system for OptiLock Port catheter placement. The OptiLock Anti-coring needle is designed to gain intracutaneous access to the OptiLock Port septum for injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

Source page: https://510kreport.com/device/K021580
Methodology: https://510kreport.com/methodology