# K050916: Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]

- Pathway: 510(k) (Special)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Jun 8, 2005 after 57 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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.
16 later devices descend from it; 2 cite it directly.
0 of 28 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
- K122380: Ocelot System (2012), 14 descendants of its own
- K123532: Ocelot Pixl Catheter (2012), 12 descendants of its own
- K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console (2014), 7 descendants of its own
- K152275: Pantheris System (2015), 6 descendants of its own
- K153460: Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) (2016), 5 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 peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.

Source page: https://510kreport.com/device/K050916
Methodology: https://510kreport.com/methodology