FDA 510(k)

隔離シンエラシー・エンキャプチャー消融システム（EMH）

K番号: K234151 · 2024-08-27

決定日2024-08-27

製品コードOCL

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてAtriCure, Inc.を記載するその他の記録

K252056Isolator® Synergy™ EnCompass Clamp and Guide system（OLH、OSH、GPM100）K250371cryoICE cryoXT 冷凝固切除探头（cryoXT）K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K243157AtriCure cryoICE BOX (ACM)K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)K233959EPi-Ease epicardialアクセスデバイス（EAS）

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公式ソース

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