FDA 510(k)

Bendit2.7 可調向微导管

K 號：K200582 · 2020-06-25

決定日期2020-06-25

產品代碼KRA

諮詢委員會履歷

決定相當於

器材摘要

Bendit2.7 Steerable Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Bend IT Technologies, Ltd.. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K200582. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bendit2.7 Steerable Microcatheter?

Bendit2.7 Steerable Microcatheter is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is Bend IT Technologies, Ltd.. The 510(k) number is K200582.

When did Bendit2.7 Steerable Microcatheter receive FDA 510(k) clearance?

Bendit2.7 Steerable Microcatheter received FDA 510(k) clearance on 2020-06-25, under 510(k) number K200582.

Who is the listed applicant for Bendit2.7 Steerable Microcatheter?

The FDA 510(k) record lists Bend IT Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bendit2.7 Steerable Microcatheter?

The FDA product code for Bendit2.7 Steerable Microcatheter is KRA.

其他以 Bend IT Technologies, Ltd. 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。

K252213Bendit17 微导管 K203842Bendit21 微导管 K190126Bendit2.7 可調向微导管

相關器械（代碼：KRA）

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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