FDA 510(k)

EPi-Ease epicardialアクセスデバイス（EAS）

K番号: K233959 · 2024-02-13

決定日2024-02-13

製品コードDYB

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定大幅同等

医療機器の概要

EPi-Ease Epicardial Access Device (EAS) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2024-02-13 under 510(k) number K233959. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the EPi-Ease Epicardial Access Device (EAS)?

EPi-Ease Epicardial Access Device (EAS) is a medical device that received FDA 510(k) clearance on 2024-02-13. The listed applicant is AtriCure, Inc.. The 510(k) number is K233959.

When did EPi-Ease Epicardial Access Device (EAS) receive FDA 510(k) clearance?

EPi-Ease Epicardial Access Device (EAS) received FDA 510(k) clearance on 2024-02-13, under 510(k) number K233959.

Who is the listed applicant for EPi-Ease Epicardial Access Device (EAS)?

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 EPi-Ease Epicardial Access Device (EAS)?

The FDA product code for EPi-Ease Epicardial Access Device (EAS) is DYB.

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)K234151隔離シンエラシー・エンキャプチャー消融システム（EMH）K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)

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