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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) 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. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K223918.

When did AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub receive FDA 510(k) clearance?

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

Who is the listed applicant for AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

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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