# K031842: Safe-Cross Radio Frequency Total Occlusion Crossing System

- Pathway: 510(k) (Traditional)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Nov 21, 2003 after 158 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: 5 generations back to K890505 (1989). 10 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 51 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.
- K003483: Modified Hydrophilic Coated Guidewire (Stainless Steel Core), Lake Region Mfg., Inc. (2000) Summary page 1.

## Most influential descendants
- K040067: Clirpath Excimer Laser Catheter (2004), 36 descendants of its own
- K043465: 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 (2005), 25 descendants of its own
- K052296: Clirpath Turbo Excimer Laser Catheters (2005), 24 descendants of its own
- K052514: Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 (2005), 23 descendants of its own
- K071227: Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, Model 310-154, 314-159, 317-15 (2007), 22 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/K031842
Methodology: https://510kreport.com/methodology