# K112032: 8FR Turbo - Tandem System

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Oct 17, 2011 after 94 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K890505 (1989). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094036: Turbo-Tandem System Model 472-110, Spectranetics Corp. (2010) Summary page 2.

## Indications for use
The Turbo-Tandem® System is indicated for atherectomy of infrainguinal arteries.

Source page: https://510kreport.com/device/K112032
Methodology: https://510kreport.com/methodology