# K043446: Emmebi Central Venous Catheter Kit with Lestep Safety Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Emmebi Srl
- Decided: Feb 4, 2005 after 52 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K770977 (1977). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963320: TFX Medical Guidewire, Tfx Medical Group (1996) Summary page 1.
- K971281: Raulerson One-Step Guidewire Insertion Bulb Needle, Medcomp (1997) Summary page 1.
- (no number) Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheter: named in the summary without a submission number
- (no number) Triple Lumen Central Venous Catheter: named in the summary without a submission number
- (no number) Quad Lumen Central Venous Catheter: named in the summary without a submission number
- (no number) Micro Stick Introducer: named in the summary without a submission number

## Indications for use
The EmmeBi Lepstep Central Venous Catheter Kit is intended for short term use as an aid for catheterization of the superior vena cava for the purpose of performing parenteral infusional or nutritional therapy and to withdraw blood samples where the peripheral venous system is not practicable.

Source page: https://510kreport.com/device/K043446
Methodology: https://510kreport.com/methodology