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FDA 510(k)

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

K-Number: K201081 · 2020-12-17

ApplicantPhilips Medical System Nederland B.V.
Decision Date2020-12-17
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter is a medical device manufactured by Philips Medical System Nederland B.V.. It received FDA 510(k) clearance on 2020-12-17 under approval number K201081. 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, AltaTrack Guidewire, AltaTrack Catheter?

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter is a medical device that received FDA 510(k) clearance on 2020-12-17. It is manufactured by Philips Medical System Nederland B.V.. The 510(k) number is K201081.

When was AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter approved by the FDA?

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter received FDA 510(k) clearance on 2020-12-17, under approval number K201081.

What company makes AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter?

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter is manufactured by Philips Medical System Nederland B.V..

What is the FDA product code for AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter?

The FDA product code for AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter is DQK.

Related Clinical Trials

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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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