FDA 510(k)

Aqueduct 100 Plus 颈管扩张球囊导管

K号: K202427 · 2020-11-06

决定日期2020-11-06

产品代码PON

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决定实质等同

器械摘要

Aqueduct 100 Plus Cervical Dilation Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Gtimd, LLC. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K202427. The device is classified under product code PON. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aqueduct 100 Plus Cervical Dilation Balloon Catheter?

Aqueduct 100 Plus Cervical Dilation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Gtimd, LLC. The 510(k) number is K202427.

When did Aqueduct 100 Plus Cervical Dilation Balloon Catheter receive FDA 510(k) clearance?

Aqueduct 100 Plus Cervical Dilation Balloon Catheter received FDA 510(k) clearance on 2020-11-06, under 510(k) number K202427.

Who is the listed applicant for Aqueduct 100 Plus Cervical Dilation Balloon Catheter?

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

What is the FDA product code for Aqueduct 100 Plus Cervical Dilation Balloon Catheter?

The FDA product code for Aqueduct 100 Plus Cervical Dilation Balloon Catheter is PON.

列明Gtimd, LLC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。

K202433Aqueduct 200 颈管扩张球囊导管 K160664Aqueduct 100 颈管扩张器

官方来源

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