FDA 510(k)

ViewFlex Xtra ICE 絲膜燒灼針

K 號：K223077 · 2022-12-07

申請人Irvine Biomedical, A St. Jude Medical Company

決定日期2022-12-07

產品代碼OBJ

諮詢委員會履歷

決定相當於

器材摘要

ViewFlex Xtra ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Biomedical, A St. Jude Medical Company. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K223077. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ViewFlex Xtra ICE Catheter?

ViewFlex Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Irvine Biomedical, A St. Jude Medical Company. The 510(k) number is K223077.

When did ViewFlex Xtra ICE Catheter receive FDA 510(k) clearance?

ViewFlex Xtra ICE Catheter received FDA 510(k) clearance on 2022-12-07, under 510(k) number K223077.

Who is the listed applicant for ViewFlex Xtra ICE Catheter?

The FDA 510(k) record lists Irvine Biomedical, A St. Jude Medical Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViewFlex Xtra ICE Catheter?

The FDA product code for ViewFlex Xtra ICE Catheter is OBJ.

相關器械（代碼：OBJ）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OBJ）

官方來源