FDA 510(k)

Arrow 压力注射中线导管

K号: K213855 · 2022-09-02

申请人Arrow International, LLC Subsidiary of Teleflex Incorporated

决定日期2022-09-02

产品代码PND

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决定实质等同

器械摘要

Arrow Pressure Injectable Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC Subsidiary of Teleflex Incorporated. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K213855. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Arrow Pressure Injectable Midline Catheter?

Arrow Pressure Injectable Midline Catheter is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Arrow International, LLC Subsidiary of Teleflex Incorporated. The 510(k) number is K213855.

When did Arrow Pressure Injectable Midline Catheter receive FDA 510(k) clearance?

Arrow Pressure Injectable Midline Catheter received FDA 510(k) clearance on 2022-09-02, under 510(k) number K213855.

Who is the listed applicant for Arrow Pressure Injectable Midline Catheter?

The FDA 510(k) record lists Arrow International, LLC Subsidiary of Teleflex Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arrow Pressure Injectable Midline Catheter?

The FDA product code for Arrow Pressure Injectable Midline Catheter is PND.

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Arrow 压力注射中线导管

器械摘要

常见问题

相关临床试验

相关器械（代码：PND）

官方来源