FDA 510(k)

SureFlo EVD Catheter

Номер K: K170599 · 2017-08-31

Дата решения2017-08-31

Код продуктаJXG

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

SureFlo EVD Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Arkis Biosciences, Inc.. It received FDA 510(k) clearance on 2017-08-31 under 510(k) number K170599. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SureFlo EVD Catheter?

SureFlo EVD Catheter is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Arkis Biosciences, Inc.. The 510(k) number is K170599.

When did SureFlo EVD Catheter receive FDA 510(k) clearance?

SureFlo EVD Catheter received FDA 510(k) clearance on 2017-08-31, under 510(k) number K170599.

Who is the listed applicant for SureFlo EVD Catheter?

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

What is the FDA product code for SureFlo EVD Catheter?

The FDA product code for SureFlo EVD Catheter is JXG.

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: JXG)

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

Официальный источник

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