FDA 510(k)

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

K号: K222694 · 2023-04-27

决定日期2023-04-27

产品代码NTE

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K222694. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)?

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is MicroVention, Inc.. The 510(k) number is K222694.

When did EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) receive FDA 510(k) clearance?

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) received FDA 510(k) clearance on 2023-04-27, under 510(k) number K222694.

Who is the listed applicant for EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)?

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 EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)?

The FDA product code for EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) is NTE.

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 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 K211120ERIC 检索设备

查看所有 24 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。