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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 a medical device manufactured by Arrow International, LLC Subsidiary of Teleflex Incorporated. It received FDA 510(k) clearance on 2022-09-02 under approval 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. It is manufactured by Arrow International, LLC Subsidiary of Teleflex Incorporated. The 510(k) number is K213855.

When was Arrow Pressure Injectable Midline Catheter approved by the FDA?

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

What company makes Arrow Pressure Injectable Midline Catheter?

Arrow Pressure Injectable Midline Catheter is manufactured by Arrow International, LLC Subsidiary of Teleflex Incorporated.

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 Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT05372679 REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study / ACTIVE_NOT_RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING

Related Devices (Code: PND)

K162900PowerMidline CatheterC.R. Bard, Inc. K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyArrow International, Inc. (Subsidiary of Teleflex, Inc.) K153393PowerMidline CatheterC.R. Bard, Inc. K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.) K170770CT MidlineMedical Components, Inc. (dba MedComp) K170158PowerGlide ST Midline CatheterC.R. Bard, 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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