FDA 510(k)

AltaTrack оборудование, AltaTrack Гуидewire, AltaTrack Катетер

Номер K: K201081 · 2020-12-17

ЗаявительPhilips Medical System Nederland B.V.

Дата решения2020-12-17

Код продуктаDQK

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: DQK)

K261729EnSite™ X EP SystemAbbott Medical K262005Affera Интегрированная Система МаппингаMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

Официальный источник

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