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FDA 510(k)

再處理型 Lasso NAV eco 及 Lasso 2515 NAV eco 電生理學（EP）心导管

K 號：K153006 · 2016-06-23

申請人Sterilmed, Inc.
決定日期2016-06-23
產品代碼NLH
諮詢委員會履歷
決定相當於

器材摘要

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153006. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter?

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Sterilmed, Inc.. The 510(k) number is K153006.

When did Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter receive FDA 510(k) clearance?

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153006.

Who is the listed applicant for Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter?

The FDA 510(k) record lists Sterilmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter?

The FDA product code for Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter is NLH.

相關臨床試驗

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其他以 Sterilmed, Inc. 為申請人之記錄

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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相關器械（代碼：NLH）

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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