# K955587: Vascular Access Port Kit

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 21, 1996 after 105 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. The FDA summary names its predicate without a number.
- (no number) VITAL-PORT MINI Vascular Access Port with Detached Catheter: named in the summary without a submission number
- (no number) PORT-A-CATH Implantable Access System: named in the summary without a submission number

## Indications for use
Impiantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. The port kit, which is the subject of this premarket notification, provides procedural components necessary for percutaneous insertion of the implantable vascular access system.

Source page: https://510kreport.com/device/K955587
Methodology: https://510kreport.com/methodology