FDA 510(k)

BD Prevue™ II 周辺静脈アクセスシステム

K番号: K240146 · 2024-02-18

決定日2024-02-18

製品コードIYO

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

BD Prevue™ II Peripheral Vascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2024-02-18 under 510(k) number K240146. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the BD Prevue™ II Peripheral Vascular Access System?

BD Prevue™ II Peripheral Vascular Access System is a medical device that received FDA 510(k) clearance on 2024-02-18. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K240146.

When did BD Prevue™ II Peripheral Vascular Access System receive FDA 510(k) clearance?

BD Prevue™ II Peripheral Vascular Access System received FDA 510(k) clearance on 2024-02-18, under 510(k) number K240146.

Who is the listed applicant for BD Prevue™ II Peripheral Vascular Access System?

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

What is the FDA product code for BD Prevue™ II Peripheral Vascular Access System?

The FDA product code for BD Prevue™ II Peripheral Vascular Access System is IYO.

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

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