伊赫爾 Panacea 靜脈栓塞切除針筒系統
K 號：K182167 · 2018-12-21
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器材摘要
The ICHOR Panacea Vascular Embolectomy Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Ichor Vascular, Inc.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182167. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the The ICHOR Panacea Vascular Embolectomy Catheter System?
The ICHOR Panacea Vascular Embolectomy Catheter System is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Ichor Vascular, Inc.. The 510(k) number is K182167.
When did The ICHOR Panacea Vascular Embolectomy Catheter System receive FDA 510(k) clearance?
The ICHOR Panacea Vascular Embolectomy Catheter System received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182167.
Who is the listed applicant for The ICHOR Panacea Vascular Embolectomy Catheter System?
The FDA 510(k) record lists Ichor Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The ICHOR Panacea Vascular Embolectomy Catheter System?
The FDA product code for The ICHOR Panacea Vascular Embolectomy Catheter System is QEW.
相關臨床試驗
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相關器械（代碼：QEW）
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。
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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