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FDA 510(k)

Kyphoplasty Balloon Catheter

K-Number: K223709 · 2023-08-16

ApplicantJiangsu Changmei Medtech Co., Ltd.
Decision Date2023-08-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Kyphoplasty Balloon Catheter?

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

When was Kyphoplasty Balloon Catheter approved by the FDA?

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

What company makes Kyphoplasty Balloon Catheter?

Kyphoplasty Balloon Catheter is manufactured by Jiangsu Changmei Medtech Co., Ltd..

What is the FDA product code for Kyphoplasty Balloon Catheter?

The FDA product code for Kyphoplasty Balloon Catheter is HRX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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