# K201081: AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical System Nederland B.V.
- Decided: Dec 17, 2020 after 239 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921310 (1992). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162643: MediGuide Technology System, St Jude Medical (2016) Summary page 4.
- K152740: Radifocus Glidewire, Ashitaka Factory of Terumo Corp. (2015) Summary page 4.
- K150232: Radifocus Optitorque Angiographic Catheter, Ashitaka Factory of Terumo Corp. (2015) Summary page 4.

## Most influential descendants
- K223918: AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub (2023), 2 descendants of its own
- K233853: LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub (2024), 1 descendant of its own
- K252645: LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (2025), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K201081
Methodology: https://510kreport.com/methodology