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FDA 510(k)

Kyphoplasty Balloon Dilatation Catheters

K-Number: K252458 · 2025-11-03

ApplicantShanghai Lange Medtech Co., Ltd.
Decision Date2025-11-03
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kyphoplasty Balloon Dilatation Catheters is a medical device manufactured by Shanghai Lange Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-11-03 under approval number K252458. 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 Dilatation Catheters?

Kyphoplasty Balloon Dilatation Catheters is a medical device that received FDA 510(k) clearance on 2025-11-03. It is manufactured by Shanghai Lange Medtech Co., Ltd.. The 510(k) number is K252458.

When was Kyphoplasty Balloon Dilatation Catheters approved by the FDA?

Kyphoplasty Balloon Dilatation Catheters received FDA 510(k) clearance on 2025-11-03, under approval number K252458.

What company makes Kyphoplasty Balloon Dilatation Catheters?

Kyphoplasty Balloon Dilatation Catheters is manufactured by Shanghai Lange Medtech Co., Ltd..

What is the FDA product code for Kyphoplasty Balloon Dilatation Catheters?

The FDA product code for Kyphoplasty Balloon Dilatation Catheters is HRX.

Related Clinical Trials

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Related Devices (Code: 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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