FDA 510(k)

Solitaire X 重建装置

K号: K203358 · 2021-03-01

申请人Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

决定日期2021-03-01

产品代码POL

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Solitaire X Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K203358. The device is classified under product code POL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Solitaire X Revascularization Device?

Solitaire X Revascularization Device is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K203358.

When did Solitaire X Revascularization Device receive FDA 510(k) clearance?

Solitaire X Revascularization Device received FDA 510(k) clearance on 2021-03-01, under 510(k) number K203358.

Who is the listed applicant for Solitaire X Revascularization Device?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solitaire X Revascularization Device?

The FDA product code for Solitaire X Revascularization Device is POL.

列明Micro Therapeutics, Inc. d/b/a ev3 Neurovascular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。

K241388Rist 079 桡动脉入路引导导管；Rist 071 桡动脉入路引导导管；Rist 桡动脉选择性导管 K243418Riptide™ 吸引泵；Riptide™ 收集罐与中间软管 K243080Riptide 吸引系统 K211990Rist 071 桡动脉入路引导导管 K203432Axium 可拆卸线圈；Axium Prime 可拆卸线圈 K202850Concerto Versa, 可拆卸线圈

查看所有 27 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。