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510(k) Data Aggregation
K Number
K201081Device Name
AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter
Manufacturer
Date Cleared
2020-12-17
(239 days)
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
Philips Medical System Nederland B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AltaTrack equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Catheter and/or AltaTrack Guidewire during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire.
The AltaTrack Guidewire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter during navigation in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
The AltaTrack Catheter is an angiographic catheter with Fiber Optic RealShape (FORS) technology, intended to deliver radiopaque media or lead a guidewire in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
Device Description
AltaTrack equipment: The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available. The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.
AltaTrack Guidewire: The AltaTrack Guidewire is a single-use, sterile, hydrophilic guidewire with FORS technology. The primary function of the AltaTrack Guidewire is to direct an AltaTrack Catheter or other compatible catheter to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology.
AltaTrack Catheter: The AltaTrack Catheter is a single-use, sterile, angiographic catheter with FORS technology. Its primary function is to deliver radiopaque media or lead an AltaTrack Guidewire or other compatible quidewire to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology.
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