# K043465: 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Aug 18, 2005 after 246 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). 26 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040067: Clirpath Excimer Laser Catheter, Spectranetics Corp. (2004) Summary page 1.

## Most influential descendants
- 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
- K091299: Spectranetics Turbo-Tandem System (2009), 20 descendants of its own
- K094036: Turbo-Tandem System Model 472-110 (2010), 19 descendants of its own

## Indications for use
For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where totat obstructions can not be crossed with standard guide wires.

Source page: https://510kreport.com/device/K043465
Methodology: https://510kreport.com/methodology