# K152181: Turbo-Power Laser Atherectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics, Inc.
- Decided: Nov 12, 2015 after 100 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: 14 generations back to K890505 (1989). 40 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K140775: Turbo-Elite Atherectomy Catheters, Turbo Tandem System, Spectranetics Corporation (2014) Summary page 4.

## Most influential descendants
- K162561: Turbo-Power (2.0mm) Laser Atherectomy Catheters (2017), 3 descendants of its own
- K172687: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (2017), 2 descendants of its own
- K180694: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (2018), 1 descendant of its own
- K222837: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (2022), 0 descendants of its own

## Recalls of this device
- Jan 15, 2016 · Class II · Z-0758-2016: The product is labeled with an expiration date that is past its shelf life.

## Indications for use
Turbo-Power™ Laser Atherectomy Catheter 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/K152181
Methodology: https://510kreport.com/methodology