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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical System Nederland B.V.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) 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. The listed applicant is Philips Medical System Nederland B.V.. The 510(k) number is K201081.

When did AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter?

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

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06958731In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled TrialENROLLING_BY_INVITATION

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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