Spectranetics Corporation
6 product lines across 2 device categories: Atherectomy, Drug-coated balloons.
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About Spectranetics Corporation
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Atherectomy Devices
Used in: Peripheral Atherectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Turbo-Elite Laser Atherectomy Catheter | Outer Diameter: 0.97–2.6 mm; Length: 112–150 cm | 12 | Not stated |
| Turbo Elite Turbo-Elite™ Laser Atherectomy Catheter | Outer Diameter: 2.3–2.6 mm | 4 | Not stated |
| Turbo-Power Turbo-Power™ Laser Atherectomy Catheter | Outer Diameter: 2–2.3 mm | 4 | Not stated |
| Turbo Tandem Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter | Length: 110 cm | 4 | Not stated |
| Turbo-Power Laser Atherectomy Catheter | Outer Diameter: 2–2.3 mm; Length: 125–150 cm; Lumen/Inner Diameter: 0.02 in | 2 | Not stated |
Drug-Coated Balloons
Used in: Peripheral Balloon Angioplasty, Peripheral Atherectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Stellarex Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 135cm | Balloon Diameter: 4–6 mm; Balloon Length: 40–200 mm; Catheter Length: 80–135 cm | 42 | Not stated |
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FDA clearances and approvals
- turbo-power 2 0mm laser atherectomy catheters turbo-power 2 3mm laser atherectomy catheters 510K K222837, 2022
- stellarex 0 035 otw drug-coated angioplasty ballon PMA P160049, 2019
- turbo-power 2 0mm laser atherectomy catheters 510K K162561, 2017
- turbo-power laser atherectomy catheter 510K K152181, 2015
- turbo-elite atherectomy catheters turbo tandem system 510K K140775, 2014
- 8fr turbo - tandem system 510K K112032, 2011
Product lines, models and sizes are compiled from the FDA Global Unique Device Identification Database (GUDID) and FDA clearance records. Descriptions marked "Provided by the manufacturer" come from the company and are reviewed before publishing.