FDA 510(k)

CROSSER CTO Recanalization Catheter

Номер K: K161208 · 2016-05-24

Дата решения2016-05-24

Код продуктаPDU

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

CROSSER CTO Recanalization Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vacular, Inc.. It received FDA 510(k) clearance on 2016-05-24 under 510(k) number K161208. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the CROSSER CTO Recanalization Catheter?

CROSSER CTO Recanalization Catheter is a medical device that received FDA 510(k) clearance on 2016-05-24. The listed applicant is Bard Peripheral Vacular, Inc.. The 510(k) number is K161208.

When did CROSSER CTO Recanalization Catheter receive FDA 510(k) clearance?

CROSSER CTO Recanalization Catheter received FDA 510(k) clearance on 2016-05-24, under 510(k) number K161208.

Who is the listed applicant for CROSSER CTO Recanalization Catheter?

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

What is the FDA product code for CROSSER CTO Recanalization Catheter?

The FDA product code for CROSSER CTO Recanalization Catheter is PDU.

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: PDU)

K262013Kiba CTO Crossing CatheterReflow Medical, Inc.K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.

Официальный источник

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