FDA 510(k)

MultiCath, AcQRate Dx 固定曲线导管

K号: K201445 · 2021-09-02

决定日期2021-09-02

产品代码DRF

咨询委员会CV

决定Substantially Equivalent

器械摘要

MultiCath, AcQRate Dx Fixed Curve Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2021-09-02 under 510(k) number K201445. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MultiCath, AcQRate Dx Fixed Curve Catheter?

MultiCath, AcQRate Dx Fixed Curve Catheter is a medical device that received FDA 510(k) clearance on 2021-09-02. The listed applicant is Biotronik, Inc.. The 510(k) number is K201445.

When did MultiCath, AcQRate Dx Fixed Curve Catheter receive FDA 510(k) clearance?

MultiCath, AcQRate Dx Fixed Curve Catheter received FDA 510(k) clearance on 2021-09-02, under 510(k) number K201445.

Who is the listed applicant for MultiCath, AcQRate Dx Fixed Curve Catheter?

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

What is the FDA product code for MultiCath, AcQRate Dx Fixed Curve Catheter?

The FDA product code for MultiCath, AcQRate Dx Fixed Curve Catheter is DRF.

列明Biotronik, 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。

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