FDA 510(k)

EasyMap MAP Catheter

Номер K: K151139 · 2016-10-18

Дата решения2016-10-18

Код продуктаDRF

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

EasyMap MAP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medfact Engineering GmbH. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K151139. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the EasyMap MAP Catheter?

EasyMap MAP Catheter is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Medfact Engineering GmbH. The 510(k) number is K151139.

When did EasyMap MAP Catheter receive FDA 510(k) clearance?

EasyMap MAP Catheter received FDA 510(k) clearance on 2016-10-18, under 510(k) number K151139.

Who is the listed applicant for EasyMap MAP Catheter?

The FDA 510(k) record lists Medfact Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyMap MAP Catheter?

The FDA product code for EasyMap MAP Catheter is DRF.

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: DRF)

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

Официальный источник

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