FDA 510(k)

CELLO II Balloon Guide Catheter

Номер K: K223275 · 2022-12-09

Дата решения2022-12-09

Код продуктаQJP

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

CELLO II Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Systems Corporation. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K223275. 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 CELLO II Balloon Guide Catheter?

CELLO II Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Fuji Systems Corporation. The 510(k) number is K223275.

When did CELLO II Balloon Guide Catheter receive FDA 510(k) clearance?

CELLO II Balloon Guide Catheter received FDA 510(k) clearance on 2022-12-09, under 510(k) number K223275.

Who is the listed applicant for CELLO II Balloon Guide Catheter?

The FDA 510(k) record lists Fuji Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELLO II Balloon Guide Catheter?

The FDA product code for CELLO II Balloon Guide Catheter 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.

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: 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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