# K021323: Modification to Safe-Steer Guide Wire System

- Pathway: 510(k) (Special)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: May 22, 2002 after 26 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K890505 (1989). 8 ancestors in all.
75 later devices descend from it; 2 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011986: Safe-Steer Guide Wire System, Intra Luminal Therapeutics, Inc. (2002)

## Most influential descendants
- K031842: Safe-Cross Radio Frequency Total Occlusion Crossing System (2003), 40 descendants of its own
- K040067: Clirpath Excimer Laser Catheter (2004), 36 descendants of its own
- K032031: Safe-Cross Radio Frequency Total Occlusion Crossing System (2004), 36 descendants of its own
- K062868: The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 (2007), 31 descendants of its own
- K072776: The Crosser System (2007), 28 descendants of its own

## Indications for use
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.

Source page: https://510kreport.com/device/K021323
Methodology: https://510kreport.com/methodology