# K905840: Strato Port Introducer KT (10 FR) LPS 5057/Modified

- Pathway: 510(k) (Traditional)
- Applicant: Strato Medical Corp.
- Decided: Apr 19, 1991 after 113 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 1 (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
- Sep 27, 2010 · Not classified · Z-0405-2011: Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

Source page: https://510kreport.com/device/K905840
Methodology: https://510kreport.com/methodology