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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Lange Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-11-03 under 510(k) 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. The listed applicant is Shanghai Lange Medtech Co., Ltd.. The 510(k) number is K252458.

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

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

Who is the listed applicant for Kyphoplasty Balloon Dilatation Catheters?

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

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

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

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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