FDA 510(k)

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

K-번호: K153533 · 2016-07-05

결정일2016-07-05

제품 코드DYB

자문 위원회CV

결정Substantially Equivalent

기기 요약

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Galt Medical Corp.. It received FDA 510(k) clearance on 2016-07-05 under 510(k) number K153533. 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 Tearaway Introducer Sheath, MicroSlide Tearaway Introducer?

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer is a medical device that received FDA 510(k) clearance on 2016-07-05. The listed applicant is Galt Medical Corp.. The 510(k) number is K153533.

When did Tearaway Introducer Sheath, MicroSlide Tearaway Introducer receive FDA 510(k) clearance?

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer received FDA 510(k) clearance on 2016-07-05, under 510(k) number K153533.

Who is the listed applicant for Tearaway Introducer Sheath, MicroSlide Tearaway Introducer?

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

What is the FDA product code for Tearaway Introducer Sheath, MicroSlide Tearaway Introducer?

The FDA product code for Tearaway Introducer Sheath, MicroSlide Tearaway Introducer is DYB.

Galt Medical Corp.를 신청인으로 등재한 기타 기록

K192195Sterile Dilator K182660GaltTWS K173287Elite HV Radial K172487Coaxial Dilator Set (Micro-Introducer)

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