# K170059: Spectranetics Turbo-Elite Laser Atherectomy Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics, Inc.
- Decided: Apr 7, 2017 after 91 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K890505 (1989). 40 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140775: Turbo-Elite Atherectomy Catheters, Turbo Tandem System, Spectranetics Corporation (2014) Summary page 4.

## Most influential descendants
- K250385: Turbo-Elite Laser Atherectomy Catheter (2025), 0 descendants of its own
- K220171: NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter (2022), 0 descendants of its own

## 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
- Nov 15, 2023 · Class II · Z-0509-2024: Incorrect product labeling. Exterior product box label does not match internal pouch label.
- Jun 6, 2017 · Class II · Z-2863-2017: Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-

## Indications for use
The Turbo-Elite devices are indicated for use in the 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/K170059
Methodology: https://510kreport.com/methodology