FDA 510(k)

Isolator Synergy EnCapture Ablation System (EMH)

K-번호: K234151 · 2024-08-27

결정일2024-08-27

제품 코드OCL

자문 위원회SU

결정Substantially Equivalent

기기 요약

Isolator Synergy EnCapture Ablation System (EMH) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K234151. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Isolator Synergy EnCapture Ablation System (EMH)?

Isolator Synergy EnCapture Ablation System (EMH) is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is AtriCure, Inc.. The 510(k) number is K234151.

When did Isolator Synergy EnCapture Ablation System (EMH) receive FDA 510(k) clearance?

Isolator Synergy EnCapture Ablation System (EMH) received FDA 510(k) clearance on 2024-08-27, under 510(k) number K234151.

Who is the listed applicant for Isolator Synergy EnCapture Ablation System (EMH)?

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

What is the FDA product code for Isolator Synergy EnCapture Ablation System (EMH)?

The FDA product code for Isolator Synergy EnCapture Ablation System (EMH) is OCL.

AtriCure, Inc.를 신청인으로 등재한 기타 기록

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)K250371cryoICE cryoXT cryoablation probe (cryoXT)K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K243157AtriCure cryoICE BOX (ACM)K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)K233959EPi-Ease Epicardial Access Device (EAS)

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