# K982507: Mini Polyurethane Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Med Institute, Inc.
- Decided: Sep 16, 1998 after 58 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 system catheters: named in the summary without a submission number

## Indications for use
The Mini Polyurethane Catheter is intended for use with single-chamber Vital Port® reservoirs for use In patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

Source page: https://510kreport.com/device/K982507
Methodology: https://510kreport.com/methodology