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FDA 510(k)

Arrow Endurance Extended Dwell Peripheral Catheter System

K-Number: K163513 · 2017-02-24

ApplicantArrow International, Inc. (Subsidiary of Teleflex, Inc.)
Decision Date2017-02-24
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Arrow Endurance Extended Dwell Peripheral Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K163513. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arrow Endurance Extended Dwell Peripheral Catheter System?

Arrow Endurance Extended Dwell Peripheral Catheter System is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K163513.

When did Arrow Endurance Extended Dwell Peripheral Catheter System receive FDA 510(k) clearance?

Arrow Endurance Extended Dwell Peripheral Catheter System received FDA 510(k) clearance on 2017-02-24, under 510(k) number K163513.

Who is the listed applicant for Arrow Endurance Extended Dwell Peripheral Catheter System?

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

What is the FDA product code for Arrow Endurance Extended Dwell Peripheral Catheter System?

The FDA product code for Arrow Endurance Extended Dwell Peripheral Catheter System is FOZ.

Related Clinical Trials

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.

NCT06675786The Effect of Catheter Protector on Catheter Dwell Time and ComplicationsCOMPLETEDNCT07779317Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered NursesRECRUITING

Other records listing Arrow International, Inc. (Subsidiary of Teleflex, Inc.) as applicant

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.

K180395EZ-IO Intraosseous Vascular Access SystemK161765CG+ Arrow JACCK161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyK160018Arrow Quickflash Arterial Catheterization DeviceK153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSK153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

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Related Devices (Code: FOZ)

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.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

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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