# K180694: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

- Pathway: 510(k) (Special)
- Applicant: Spectranetics, Inc.
- Decided: Apr 5, 2018 after 20 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: 17 generations back to K890505 (1989). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172687: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters, Spectranetics, Inc. (2017) Summary page 4.

## Most influential descendants
- K222837: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (2022), 0 descendants of its own

## Indications for use
Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

Source page: https://510kreport.com/device/K180694
Methodology: https://510kreport.com/methodology