FDA 510(k)

Route 92 Medical 088 Access System

Номер K: K201518 · 2020-08-14

Дата решения2020-08-14

Код продуктаQJP

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Route 92 Medical 088 Access System is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K201518. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Route 92 Medical 088 Access System?

Route 92 Medical 088 Access System is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is Route 92 Medical. The 510(k) number is K201518.

When did Route 92 Medical 088 Access System receive FDA 510(k) clearance?

Route 92 Medical 088 Access System received FDA 510(k) clearance on 2020-08-14, under 510(k) number K201518.

Who is the listed applicant for Route 92 Medical 088 Access System?

The FDA 510(k) record lists Route 92 Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Route 92 Medical 088 Access System?

The FDA product code for Route 92 Medical 088 Access System is QJP.

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: QJP)

K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.K26227770 NeuGlide CatheterPiraeus Medical, Inc.K261176Zoom 4S CatheterImperative Care, Inc.K254071p17 XR MicrocatheterWallaby Medical K260199SLIM MicrocatheterBalt USA, LLC K253901Millipede88 Access CatheterPerfuze, Ltd.

Официальный источник

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