# K050915: Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]

- Pathway: 510(k) (Special)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Jun 7, 2005 after 56 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: 7 generations back to K890505 (1989). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040037: Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System, Intra Luminal Therapeutics, Inc. (2004) Summary page 1.

## Most influential descendants
- K073162: Safe-Cross (R) Radio Frequency Total Occlusion Crossing System, Safe-Cross (R) Radio Frequency Total Occlusion Crossing (2008), 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 percutaneous interventions in native coronary arteries with total occlusions.

Source page: https://510kreport.com/device/K050915
Methodology: https://510kreport.com/methodology