FDA 510(k)

MicroPlex线圈系统（MCS），Hydrocoil栓塞系统（HES）

K号: K153594 · 2016-01-22

决定日期2016-01-22

产品代码HCG

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决定实质等同

器械摘要

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.

常见问题

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.

列明MicroVention, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232542楔形XL输送导管 K230775SOFIA EX颅内支撑导管 K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)K222115ISAAC 神经血管导航导管 K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)K214024SOFIA 88导管

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相关器械（代码：HCG）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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