FDA 510(k)

AtriClip PRO-Mini LAA Exclusion System (PROM)

K番号: K243860 · 2025-01-15

決定日2025-01-15

製品コードPZX

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

AtriClip PRO-Mini LAA Exclusion System (PROM) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2025-01-15 under 510(k) number K243860. The device is classified under product code PZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the AtriClip PRO-Mini LAA Exclusion System (PROM)?

AtriClip PRO-Mini LAA Exclusion System (PROM) is a medical device that received FDA 510(k) clearance on 2025-01-15. The listed applicant is AtriCure, Inc.. The 510(k) number is K243860.

When did AtriClip PRO-Mini LAA Exclusion System (PROM) receive FDA 510(k) clearance?

AtriClip PRO-Mini LAA Exclusion System (PROM) received FDA 510(k) clearance on 2025-01-15, under 510(k) number K243860.

Who is the listed applicant for AtriClip PRO-Mini LAA Exclusion System (PROM)?

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 AtriClip PRO-Mini LAA Exclusion System (PROM)?

The FDA product code for AtriClip PRO-Mini LAA Exclusion System (PROM) is PZX.

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）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)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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