FDA 510(k)

cryoFORM cryoICE cryoablation probe 冷凍フォーム冷凍アイス冷凍焼灼プローブ

K番号: K152337 · 2016-03-22

決定日2016-03-22

製品コードGEH

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

cryoFORM cryoICE cryoablation probe is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2016-03-22 under 510(k) number K152337. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the cryoFORM cryoICE cryoablation probe?

cryoFORM cryoICE cryoablation probe is a medical device that received FDA 510(k) clearance on 2016-03-22. The listed applicant is AtriCure, Inc.. The 510(k) number is K152337.

When did cryoFORM cryoICE cryoablation probe receive FDA 510(k) clearance?

cryoFORM cryoICE cryoablation probe received FDA 510(k) clearance on 2016-03-22, under 510(k) number K152337.

Who is the listed applicant for cryoFORM cryoICE cryoablation probe?

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 cryoFORM cryoICE cryoablation probe?

The FDA product code for cryoFORM cryoICE cryoablation probe is GEH.

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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