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510(k) Data Aggregation
K Number
K220171Device Name
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
Manufacturer
Northeast Scientific, Inc.
Date Cleared
2022-07-01
(161 days)
Product Code
QTF
Regulation Number
870.4875Why did this record match?
Product Code :
QTF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter (0.014" guidewire compatible and over-the-wire configuration) is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
The 0.014" 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 nutinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).
Device Description
The NES Reprocessed Spectranetics Turbo-Elite Laser Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen. Catheter sizing identification is printed on the catheters.
For NES Reprocessed Spectranetics Turbo-Elite Laser Catheters, Over-The-Wire (OTW) catheters, a Luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriately sized guidewire.
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