# K091299: Spectranetics Turbo-Tandem System

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Jul 1, 2009 after 58 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: 11 generations back to K890505 (1989). 37 ancestors in all.
20 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)
- K071227: Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, Model 310-154, 314-159, 317-15, Spectranetics Corp. (2007) Summary page 2.
- K071226: 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043, Spectranetics Corp. (2007) Summary page 2.

## Most influential descendants
- K094036: Turbo-Tandem System Model 472-110 (2010), 19 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K091299
Methodology: https://510kreport.com/methodology