脊椎成形術氣球擴張導管
K 號：K252458 · 2025-11-03
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器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：HRX）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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