FDA 510(k)

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)

Номер K: K202694 · 2021-01-14

Дата решения2021-01-14

Код продуктаGZT

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is the device name listed in this FDA 510(k) record. The listed applicant is Vycor Medical, Inc.. It received FDA 510(k) clearance on 2021-01-14 under 510(k) number K202694. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)?

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is a medical device that received FDA 510(k) clearance on 2021-01-14. The listed applicant is Vycor Medical, Inc.. The 510(k) number is K202694.

When did Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) receive FDA 510(k) clearance?

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) received FDA 510(k) clearance on 2021-01-14, under 510(k) number K202694.

Who is the listed applicant for Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)?

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

What is the FDA product code for Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)?

The FDA product code for Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is GZT.

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: GZT)

K252995Durashield Device KitSurGenTec, LLC K210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH K172433NICO BrainPathNico Corporation K161680MEDICON Spinal Spreading SystemsMedicon EG

Официальный источник

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