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FDA 510(k)

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

K-Number: K223918 · 2023-06-08

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2023-06-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2023-06-08 under approval number K223918. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub?

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub is a medical device that received FDA 510(k) clearance on 2023-06-08. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K223918.

When was AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub approved by the FDA?

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub received FDA 510(k) clearance on 2023-06-08, under approval number K223918.

What company makes AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub?

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub?

The FDA product code for AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub is DQK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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