FDA 510(k)

患者特异性气道支架

K号: K182743 · 2019-10-23

决定日期2019-10-23

产品代码NWA

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决定实质等同

器械摘要

Patient-Specific Airway Stent is the device name listed in this FDA 510(k) record. The listed applicant is New Cos, Inc.. It received FDA 510(k) clearance on 2019-10-23 under 510(k) number K182743. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Patient-Specific Airway Stent?

Patient-Specific Airway Stent is a medical device that received FDA 510(k) clearance on 2019-10-23. The listed applicant is New Cos, Inc.. The 510(k) number is K182743.

When did Patient-Specific Airway Stent receive FDA 510(k) clearance?

Patient-Specific Airway Stent received FDA 510(k) clearance on 2019-10-23, under 510(k) number K182743.

Who is the listed applicant for Patient-Specific Airway Stent?

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

What is the FDA product code for Patient-Specific Airway Stent?

The FDA product code for Patient-Specific Airway Stent is NWA.

官方来源

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患者特异性气道支架

器械摘要

常见问题

相关临床试验

相关器械（代码：NWA）

官方来源