# K040067: Clirpath Excimer Laser Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Apr 27, 2004 after 104 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: 6 generations back to K890505 (1989). 25 ancestors in all.
36 later devices descend from it; 4 cite it directly.
0 of 62 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.
- K901206: Rotablator, Heart Technology, Inc. (1990). Our OCR of the scanned summary read K801206, FDA’s number for Emit Valproic Acid Control (Syva Co.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Rotablator Rotational Angioplasty Systems”.
- K933238: Rotablator, Modification, Heart Technology, Inc. (1993). Our OCR of the scanned summary read K933328, FDA’s number for Damor Creme (Damor America, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Rotablator Rotational Angioplasty Systems”.
- K023114: Lumend Frontrunner Cto Catheter, Lumend, Inc. (2003) Summary page 1.
- K024243: Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406, Fox Hollow Technologies (2003) Summary page 1.

## Most influential descendants
- 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
- K091299: Spectranetics Turbo-Tandem System (2009), 20 descendants of its own

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

Source page: https://510kreport.com/device/K040067
Methodology: https://510kreport.com/methodology