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FDA 510(k)

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

K-Number: K161313 · 2016-08-24

ApplicantArrow International, Inc. (Subsidiary of Teleflex, Inc.)
Decision Date2016-08-24
Product CodePND
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is a medical device manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-08-24 under approval number K161313. 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 with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is a medical device that received FDA 510(k) clearance on 2016-08-24. It is manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K161313.

When was ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology approved by the FDA?

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology received FDA 510(k) clearance on 2016-08-24, under approval number K161313.

What company makes ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.).

What is the FDA product code for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

The FDA product code for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is PND.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments 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 NCT07601997 Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (REFINE Study) NOT_YET_RECRUITING

Other Devices by Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K160018Arrow Quickflash Arterial Catheterization Device K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC K163513Arrow Endurance Extended Dwell Peripheral Catheter System K180395EZ-IO Intraosseous Vascular Access System

Related Devices (Code: PND)

K162900PowerMidline CatheterC.R. Bard, 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. K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USA

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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