FDA 510(k)

AcQCross Qx 통합 전 Across 경부 확장기/나이프

K-번호: K210685 · 2021-04-06

결정일2021-04-06

제품 코드DYB

자문 위원회CV

결정Substantially Equivalent

기기 요약

AcQCross Qx Integrated Transseptal Dilator/Needle is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2021-04-06 under 510(k) number K210685. 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 AcQCross Qx Integrated Transseptal Dilator/Needle?

AcQCross Qx Integrated Transseptal Dilator/Needle is a medical device that received FDA 510(k) clearance on 2021-04-06. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K210685.

When did AcQCross Qx Integrated Transseptal Dilator/Needle receive FDA 510(k) clearance?

AcQCross Qx Integrated Transseptal Dilator/Needle received FDA 510(k) clearance on 2021-04-06, under 510(k) number K210685.

Who is the listed applicant for AcQCross Qx Integrated Transseptal Dilator/Needle?

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

What is the FDA product code for AcQCross Qx Integrated Transseptal Dilator/Needle?

The FDA product code for AcQCross Qx Integrated Transseptal Dilator/Needle is DYB.

Acutus Medical, Inc.를 신청인으로 등재한 기타 기록

K233691FlexCath Cross Transseptal Solution K231091AcQMap High Resolution Imaging and Mapping System K230606AcQMap® High Resolution Imaging and Mapping System K222209AcQMap High Resolution Imaging and Mapping System K220784AcQMap High Resolution Imaging and Mapping System K210766AcQMap 3D Imaging and Mapping Catheter, Model 900009

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