FDA 510(k)

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

K-번호: K220305 · 2022-10-28

결정일2022-10-28

제품 코드PZX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is the device name listed in this FDA 510(k) record. The listed applicant is Syntheon. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K220305. The device is classified under product code PZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Syntheon. The 510(k) number is K220305.

When did Syntheon LAA Exclusion System, Syntheon LAA Selection Guide receive FDA 510(k) clearance?

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide received FDA 510(k) clearance on 2022-10-28, under 510(k) number K220305.

Who is the listed applicant for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

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

What is the FDA product code for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

The FDA product code for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is PZX.

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