Atherectomy
Turbo Tandem
A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.
Turbo Tandem models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 472-110 | Length 110 cm | Not stated | Available |
| 472-110AA | Length 110 cm | Not stated | Available |
| 482-110 | Length 110 cm | Not stated | Available |
| 482-110AA | Length 110 cm | Not stated | Available |
FDA clearances
- 510(k) K140775 July 2014
- 510(k) K112032 October 2011
- 510(k) K094036 January 2010
Procedures that use atherectomy
Frequently asked questions
What is Turbo Tandem used for?
A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.
Who makes Turbo Tandem?
Turbo Tandem is made by Spectranetics Corporation. It is listed under atherectomy devices in our device library.
What sizes does Turbo Tandem come in?
Sizes listed for Turbo Tandem: Length: 110 cm. Confirm availability with the manufacturer's instructions for use.
Is Turbo Tandem MRI safe?
The FDA device database entry for Turbo Tandem does not state its MRI safety status. Check the labeling before MRI.
Is Turbo Tandem FDA cleared?
Turbo Tandem is covered by FDA submissions K112032, K140775, K094036.
How do I contact a Spectranetics Corporation sales representative?
Spectranetics Corporation has not listed representatives on LA Vascular yet. Visit the Spectranetics Corporation company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.