FDA 510(k)

Fortress Introducer Sheath SYstem

K-번호: K153197 · 2016-01-11

결정일2016-01-11

제품 코드DYB

자문 위원회CV

결정Substantially Equivalent

기기 요약

Fortress Introducer Sheath SYstem is the device name listed in this FDA 510(k) record. The listed applicant is Contract Medical International, GmbH. It received FDA 510(k) clearance on 2016-01-11 under 510(k) number K153197. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Fortress Introducer Sheath SYstem?

Fortress Introducer Sheath SYstem is a medical device that received FDA 510(k) clearance on 2016-01-11. The listed applicant is Contract Medical International, GmbH. The 510(k) number is K153197.

When did Fortress Introducer Sheath SYstem receive FDA 510(k) clearance?

Fortress Introducer Sheath SYstem received FDA 510(k) clearance on 2016-01-11, under 510(k) number K153197.

Who is the listed applicant for Fortress Introducer Sheath SYstem?

The FDA 510(k) record lists Contract Medical International, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fortress Introducer Sheath SYstem?

The FDA product code for Fortress Introducer Sheath SYstem is DYB.

Contract Medical International, GmbH를 신청인으로 등재한 기타 기록

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