# K140775: Turbo-Elite Atherectomy Catheters, Turbo Tandem System

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corporation
- Decided: Jul 23, 2014 after 117 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 3 (0 Class I)
- 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.
17 later devices descend from it; 3 cite it directly.
0 of 57 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 1.
- K091299: Spectranetics Turbo-Tandem System, Spectranetics Corp. (2009) Summary page 1.
- K060012: Clirpath Turbo Peripheral Catheters, Spectranetics Corp. (2006) Summary page 2.
- K052514: Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001, Spectranetics Corp. (2005) Summary page 2.
- K052296: Clirpath Turbo Excimer Laser Catheters, Spectranetics Corp. (2005) Summary page 2.

## Most influential descendants
- 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
- K230709: Auryon Atherectomy System (2023), 3 descendants of its own

## Recalls of this device
- Oct 31, 2016 · Class II · Z-0661-2017: Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised i
- Oct 31, 2016 · Class II · Z-0662-2017: Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised i
- Oct 31, 2016 · Class II · Z-0663-2017: Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised i

## Indications for use
The Turbo Elite devices are indicated for use in the treatment of infrainguinal stenosis and occlusions. When used in conjunction with the Turbo Booster and/or as an accessory to the Turbo Tandem System, the devices are indicated for atherectomy of infrainguinal arteries. The 0.014" and 0.018" Over-the-wire (OTW) Turbo Elite laser catheters are also indicated for use as an accessory to the use of the Turbo Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Source page: https://510kreport.com/device/K140775
Methodology: https://510kreport.com/methodology