FDA 510(k)

Pristine Long-Term Hemodialysis Catheter

Номер K: K203767 · 2021-04-02

Дата решения2021-04-02

Код продуктаMSD

Консультативный комитетGU

РешениеUnknown

Описание устройства

Pristine Long-Term Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C B Bard, Inc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K203767. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Часто задаваемые вопросы

What is the Pristine Long-Term Hemodialysis Catheter?

Pristine Long-Term Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is C B Bard, Inc.. The 510(k) number is K203767.

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

Pristine Long-Term Hemodialysis Catheter received FDA 510(k) clearance on 2021-04-02, under 510(k) number K203767.

Who is the listed applicant for Pristine Long-Term Hemodialysis Catheter?

The FDA 510(k) record lists C B Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pristine Long-Term Hemodialysis Catheter?

The FDA product code for Pristine Long-Term 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.