# K033708: Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System

- Pathway: 510(k) (Special)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Dec 11, 2003 after 15 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: 6 generations back to K890505 (1989). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031842: Safe-Cross Radio Frequency Total Occlusion Crossing System, Intra Luminal Therapeutics, Inc. (2003) Summary page 1.

## Most influential descendants
- K033929: Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System (2004), 1 descendant of its own
- K041973: Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System (2004), 0 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 vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

Source page: https://510kreport.com/device/K033708
Methodology: https://510kreport.com/methodology