FDA 510(k)

Map-it Diagnostic Mapping Catheters

Номер K: K160390 · 2016-04-11

ЗаявительAccess Point Technologies Ep, Inc.

Дата решения2016-04-11

Код продуктаDRF

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Map-it Diagnostic Mapping Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Access Point Technologies Ep, Inc.. It received FDA 510(k) clearance on 2016-04-11 under 510(k) number K160390. 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 Map-it Diagnostic Mapping Catheters?

Map-it Diagnostic Mapping Catheters is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Access Point Technologies Ep, Inc.. The 510(k) number is K160390.

When did Map-it Diagnostic Mapping Catheters receive FDA 510(k) clearance?

Map-it Diagnostic Mapping Catheters received FDA 510(k) clearance on 2016-04-11, under 510(k) number K160390.

Who is the listed applicant for Map-it Diagnostic Mapping Catheters?

The FDA 510(k) record lists Access Point Technologies Ep, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Map-it Diagnostic Mapping Catheters?

The FDA product code for Map-it Diagnostic Mapping Catheters 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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