FDA 510(k)

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

Номер K: K192289 · 2019-11-15

Дата решения2019-11-15

Код продуктаJXG

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is the device name listed in this FDA 510(k) record. The listed applicant is Irras USA, Ltd.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K192289. 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 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Irras USA, Ltd.. The 510(k) number is K192289.

When did IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit receive FDA 510(k) clearance?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192289.

Who is the listed applicant for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

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

What is the FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

The FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit 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.

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: 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

Посмотреть в базе данных FDA →

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