FDA 510(k)

087 機械導管系統

K 號：K190749 · 2019-07-15

申請人Q'Apel

決定日期2019-07-15

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

087 Balloon Guide Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel. It received FDA 510(k) clearance on 2019-07-15 under 510(k) number K190749. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 087 Balloon Guide Catheter System?

087 Balloon Guide Catheter System is a medical device that received FDA 510(k) clearance on 2019-07-15. The listed applicant is Q'Apel. The 510(k) number is K190749.

When did 087 Balloon Guide Catheter System receive FDA 510(k) clearance?

087 Balloon Guide Catheter System received FDA 510(k) clearance on 2019-07-15, under 510(k) number K190749.

Who is the listed applicant for 087 Balloon Guide Catheter System?

The FDA 510(k) record lists Q'Apel as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 087 Balloon Guide Catheter System?

The FDA product code for 087 Balloon Guide Catheter System is DQY.

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