# K073664: Frontline Medical Safetynet Guidewire Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Injectimed, Inc.
- Decided: Aug 8, 2008 after 226 days
- Product code: MDM (Instrument, Manual, Surgical, General Use)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K971165 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040029: Safetynet Guidewire Introducer, Injectimed, Inc. (2004) Summary page 1.
- K013040: Light Saber Introducer Needle, Minrad, Inc. (2001)

## Indications for use
A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.

Source page: https://510kreport.com/device/K073664
Methodology: https://510kreport.com/methodology