FDA 510(k)

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)

Número K: K153594 · 2016-01-22

Data da decisão2016-01-22

Código do produtoHCG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K153594. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is MicroVention, Inc.. The 510(k) number is K153594.

When did MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) receive FDA 510(k) clearance?

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) received FDA 510(k) clearance on 2016-01-22, under 510(k) number K153594.

Who is the listed applicant for MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

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

What is the FDA product code for MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

The FDA product code for MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is HCG.

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