FDA 510(k)

UltraCath Continuous Nerve block Catheter

K番号: K162522 · 2017-03-17

決定日2017-03-17

製品コードBSO

諮問委員会AN 当社の医療機器は、FDA（米国食品医薬品局）の規制に従って製造・販売されています。製品は、510(k)通知書およびPMA（プレマーケティング評価）を通じて承認を受けています。臨床試験情報は、NCT（臨床試験登録番号）およびPMID（PubMed ID）で確認できます。詳細情報や製品の詳細については、以下のURLをご参照ください。 [URL]

決定Substantially Equivalent

医療機器の概要

UltraCath Continuous Nerve block Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K162522. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the UltraCath Continuous Nerve block Catheter?

UltraCath Continuous Nerve block Catheter is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K162522.

When did UltraCath Continuous Nerve block Catheter receive FDA 510(k) clearance?

UltraCath Continuous Nerve block Catheter received FDA 510(k) clearance on 2017-03-17, under 510(k) number K162522.

Who is the listed applicant for UltraCath Continuous Nerve block Catheter?

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

What is the FDA product code for UltraCath Continuous Nerve block Catheter?

The FDA product code for UltraCath Continuous Nerve block Catheter is BSO.

申請者としてTeleflexmedical, Inc.を記載するその他の記録

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