# K032031: Safe-Cross Radio Frequency Total Occlusion Crossing System

- Pathway: 510(k) (Traditional)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Jan 7, 2004 after 190 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: 5 generations back to K890505 (1989). 9 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021323: Modification to Safe-Steer Guide Wire System, Intra Luminal Therapeutics, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K040037: Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System (2004), 18 descendants of its own
- K111338: Wildcat Catheter (2011), 17 descendants of its own
- K050916: Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral] (2005), 16 descendants of its own

## Indications for use
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.

Source page: https://510kreport.com/device/K032031
Methodology: https://510kreport.com/methodology