FDA 510(k)

导丝锁定装置

K号: K220247 · 2022-03-29

决定日期2022-03-29

产品代码ODC

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决定实质等同

器械摘要

Guidewire Locking Device is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2022-03-29 under 510(k) number K220247. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Guidewire Locking Device?

Guidewire Locking Device is a medical device that received FDA 510(k) clearance on 2022-03-29. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K220247.

When did Guidewire Locking Device receive FDA 510(k) clearance?

Guidewire Locking Device received FDA 510(k) clearance on 2022-03-29, under 510(k) number K220247.

Who is the listed applicant for Guidewire Locking Device?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guidewire Locking Device?

The FDA product code for Guidewire Locking Device is ODC.

列明Micro-Tech (Nanjing) Co., Ltd.为申报人的其他记录

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