# K123632: 2.5MM Turbo Elite 035, 2.3MM Turbo Elite 035

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Jan 25, 2013 after 63 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- 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: 11 generations back to K890505 (1989). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Spectranetics Corp. (2007) Summary page 2.

## Recalls of this device
- Nov 25, 2024 · Class II · Z-0680-2025: Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

## Indications for use
The Turbo Elite is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

Source page: https://510kreport.com/device/K123632
Methodology: https://510kreport.com/methodology