# K041708: Enpath Safety Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Enpath Medical Incorporated
- Decided: Nov 30, 2004 after 160 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000665 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000665: TFX Medical Safety Needle with Introducer, Tfx Medical, Inc. (2000) Summary page 1.

## Indications for use
The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system

Source page: https://510kreport.com/device/K041708
Methodology: https://510kreport.com/methodology