無限動脈內球囊导管
K 號：K192399 · 2020-05-20
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器材摘要
Infinity Angioplasty Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Infinity Angioplasty Balloon Company, LLC. It received FDA 510(k) clearance on 2020-05-20 under 510(k) number K192399. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Infinity Angioplasty Balloon Catheter?
Infinity Angioplasty Balloon Catheter is a medical device that received FDA 510(k) clearance on 2020-05-20. The listed applicant is Infinity Angioplasty Balloon Company, LLC. The 510(k) number is K192399.
When did Infinity Angioplasty Balloon Catheter receive FDA 510(k) clearance?
Infinity Angioplasty Balloon Catheter received FDA 510(k) clearance on 2020-05-20, under 510(k) number K192399.
Who is the listed applicant for Infinity Angioplasty Balloon Catheter?
The FDA 510(k) record lists Infinity Angioplasty Balloon Company, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Infinity Angioplasty Balloon Catheter?
The FDA product code for Infinity Angioplasty Balloon Catheter is LIT.
相關臨床試驗
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相關器械（代碼：LIT）
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
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