FDA 510(k)

Pristine Hemodialysis Catheter

Номер K: K182443 · 2019-05-31

ЗаявительPristine Access Technologies , Ltd.

Дата решения2019-05-31

Код продуктаMSD

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Pristine Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pristine Access Technologies , Ltd.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K182443. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Pristine Hemodialysis Catheter?

Pristine Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Pristine Access Technologies , Ltd.. The 510(k) number is K182443.

When did Pristine Hemodialysis Catheter receive FDA 510(k) clearance?

Pristine Hemodialysis Catheter received FDA 510(k) clearance on 2019-05-31, under 510(k) number K182443.

Who is the listed applicant for Pristine Hemodialysis Catheter?

The FDA 510(k) record lists Pristine Access Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pristine Hemodialysis Catheter?

The FDA product code for Pristine Hemodialysis Catheter is MSD.

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: MSD)

K241581Hemodialysis CatheterHaolang Medical USA Corporation K210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.

Официальный источник

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