# 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

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Jul 11, 2007 after 69 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K890505 (1989). 30 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060012: Clirpath Turbo Peripheral Catheters, Spectranetics Corp. (2006) Summary page 1.
- K052296: Clirpath Turbo Excimer Laser Catheters, Spectranetics Corp. (2005) Summary page 1.
- K052514: Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001, Spectranetics Corp. (2005) Summary page 1.

## Most influential descendants
- K091299: Spectranetics Turbo-Tandem System (2009), 20 descendants of its own
- K094036: Turbo-Tandem System Model 472-110 (2010), 19 descendants of its own
- K140775: Turbo-Elite Atherectomy Catheters, Turbo Tandem System (2014), 17 descendants of its own
- K181642: B-Laser Atherectomy System (2018), 8 descendants of its own
- K202835: Auryon Atherectomy System (2020), 6 descendants of its own

## Recalls of this device
- Jul 4, 2008 · Not classified · Z-0976-2009: The catheter pouch label was incorrectly labeled with the wrong size.

## Indications for use
For use in the treatment of infrainguinal stenoses and occlusions. For use in the treatment of infrainguinal stenoses and occlusions.

Source page: https://510kreport.com/device/K071227
Methodology: https://510kreport.com/methodology