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FDA 510(k)

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

K-Number: K153487 · 2016-02-04

ApplicantArrow International, Inc. (Subsidiary of Teleflex, Inc.)
Decision Date2016-02-04
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is a medical device manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-02-04 under approval number K153487. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is a medical device that received FDA 510(k) clearance on 2016-02-04. It is manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K153487.

When was CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS approved by the FDA?

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS received FDA 510(k) clearance on 2016-02-04, under approval number K153487.

What company makes CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.).

What is the FDA product code for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

The FDA product code for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is LJS.

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

K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology K160018Arrow Quickflash Arterial Catheterization Device 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: LJS)

K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) K162443PowerPICC Provena CathetersC.R. Bard, Inc. K161496Turbo-Flo PICC SetsCook Incorporated K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex K153469Cathtong I PICC CatheterL&Z Us, Inc. K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH 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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