FDA 510(k)

Kyphoplasty Balloon Catheter

Número K: K223709 · 2023-08-16

RequerenteJiangsu Changmei Medtech Co., Ltd.

Data da decisão2023-08-16

Código do produtoHRX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kyphoplasty Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Changmei Medtech Co., Ltd.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K223709. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kyphoplasty Balloon Catheter?

Kyphoplasty Balloon Catheter is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is Jiangsu Changmei Medtech Co., Ltd.. The 510(k) number is K223709.

When did Kyphoplasty Balloon Catheter receive FDA 510(k) clearance?

Kyphoplasty Balloon Catheter received FDA 510(k) clearance on 2023-08-16, under 510(k) number K223709.

Who is the listed applicant for Kyphoplasty Balloon Catheter?

The FDA 510(k) record lists Jiangsu Changmei Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kyphoplasty Balloon Catheter?

The FDA product code for Kyphoplasty Balloon Catheter is HRX.

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