# K094036: Turbo-Tandem System Model 472-110

- Pathway: 510(k) (Special)
- Applicant: Spectranetics Corp.
- Decided: Jan 25, 2010 after 26 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: 12 generations back to K890505 (1989). 38 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091299: Spectranetics Turbo-Tandem System, Spectranetics Corp. (2009) Summary page 2.

## Most influential descendants
- K140775: Turbo-Elite Atherectomy Catheters, Turbo Tandem System (2014), 17 descendants of its own
- K181642: B-Laser Atherectomy System (2018), 8 descendants of its own
- K202835: Auryon Atherectomy System (2020), 6 descendants of its own
- K220116: Auryon Atherectomy Catheters (2022), 4 descendants of its own
- K152181: Turbo-Power Laser Atherectomy Catheter (2015), 4 descendants of its own

## Indications for use
Turbo-TandeMTM System is indicated for atherectomy of infrainguinal arteries.

Source page: https://510kreport.com/device/K094036
Methodology: https://510kreport.com/methodology