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FDA 510(k)

Advisor FL 15mm 12 极 333 Uni D, Advisor FL 20mm 12 极 555 Uni D, Advisor FL 15mm 12 极 333 Bi D, Advisor FL 20mm 12 极 555 Bi D

K 號：K160335 · 2016-12-13

申請人St Jude Medical
決定日期2016-12-13
產品代碼DRF
諮詢委員會履歷
決定相當於

器材摘要

Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-12-13 under 510(k) number K160335. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D?

Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D is a medical device that received FDA 510(k) clearance on 2016-12-13. The listed applicant is St Jude Medical. The 510(k) number is K160335.

When did Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D receive FDA 510(k) clearance?

Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D received FDA 510(k) clearance on 2016-12-13, under 510(k) number K160335.

Who is the listed applicant for Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D?

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

What is the FDA product code for Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D?

The FDA product code for Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D is DRF.

相關臨床試驗

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