# K250385: Turbo-Elite Laser Atherectomy Catheter

- Pathway: 510(k) (Special)
- Applicant: Spectranetics
- Decided: Mar 13, 2025 after 30 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K890505 (1989). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170059: Spectranetics Turbo-Elite Laser Atherectomy Catheters, Spectranetics, Inc. (2017) Summary page 5.

## Indications for use
The Turbo-Elite devices are indicated for use in treatment, including atherectomy, of infrainguinal stenoses and occlusions. The 0.014" and 0.018" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Source page: https://510kreport.com/device/K250385
Methodology: https://510kreport.com/methodology