# K830233: Non-Sterile,Single/Souble Lumen-Cath

- Pathway: 510(k) (Traditional)
- Applicant: Evermed, Inc.
- Decided: Feb 28, 1983 after 34 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K041088: Trifusion, Model 0609190/0659350 (2004), 1 descendant of its own
- K172511: Hickman TriFusion Catheter (2018), 0 descendants of its own

## Recalls of this device
- Dec 12, 2025 · Class II · Z-1367-2026: Due to damage to outer tray that can potentially compromise the sterile barrier
- Feb 21, 2013 · Class II · Z-0909-2013: Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Syste
- Feb 21, 2013 · Class II · Z-0910-2013: Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Syste

Source page: https://510kreport.com/device/K830233
Methodology: https://510kreport.com/methodology