FDA 510(k)

Penumbra System ACE 64 及 ACE 68 再灌流導管

K 號：K152541 · 2016-01-13

決定日期2016-01-13

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

Penumbra System ACE 64 and ACE 68 Reperfusion Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K152541. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters?

Penumbra System ACE 64 and ACE 68 Reperfusion Catheters is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Penumbra, Inc.. The 510(k) number is K152541.

When did Penumbra System ACE 64 and ACE 68 Reperfusion Catheters receive FDA 510(k) clearance?

Penumbra System ACE 64 and ACE 68 Reperfusion Catheters received FDA 510(k) clearance on 2016-01-13, under 510(k) number K152541.

Who is the listed applicant for Penumbra System ACE 64 and ACE 68 Reperfusion Catheters?

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

What is the FDA product code for Penumbra System ACE 64 and ACE 68 Reperfusion Catheters?

The FDA product code for Penumbra System ACE 64 and ACE 68 Reperfusion Catheters is NRY.

其他以 Penumbra, 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。

K250690Penumbra 系統（Thunderbolt 吸引管）K260599INDIGO® 吸引系統 – INDIGO 鏈接 K251949INDIGO® 吸引系統 - 雷電閃吸管連結版 K252612INDIGO® 吸引系統 – 雷電閃吸管；INDIGO® 吸引系統 – 雷電閃吸管 K250079Ruby XL 系統 K242104Penumbra 系統（再灌流導管 RED 72）

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相關器械（代碼：NRY）

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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