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FDA 510(k)

Arrow Pressure Injectable Midline Catheter

K-Number: K213855 · 2022-09-02

ApplicantArrow International, LLC Subsidiary of Teleflex Incorporated
Decision Date2022-09-02
Product CodePND
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: PND)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.K213203Provena(TM) Midline CatheterC.R. Bard, Inc.K210047Stiletto Extended Dwell CatheterPiper Access, LLCK192802primeMidline CathetersPfm Medical, Inc.K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USAK173114primeMidline CathetersPfm Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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