FDA 510(k)

5 FR Dual Lumen Piper PICC

K-Number: K181904 · 2018-09-25

Decision Date2018-09-25

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

5 FR Dual Lumen Piper PICC is a medical device manufactured by Piper Access, LLC. It received FDA 510(k) clearance on 2018-09-25 under approval number K181904. 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 5 FR Dual Lumen Piper PICC?

5 FR Dual Lumen Piper PICC is a medical device that received FDA 510(k) clearance on 2018-09-25. It is manufactured by Piper Access, LLC. The 510(k) number is K181904.

When was 5 FR Dual Lumen Piper PICC approved by the FDA?

5 FR Dual Lumen Piper PICC received FDA 510(k) clearance on 2018-09-25, under approval number K181904.

What company makes 5 FR Dual Lumen Piper PICC?

5 FR Dual Lumen Piper PICC is manufactured by Piper Access, LLC.

What is the FDA product code for 5 FR Dual Lumen Piper PICC?

The FDA product code for 5 FR Dual Lumen Piper PICC is LJS.

Other Devices by Piper Access, LLC

K191976Piper GO-IO Intraosseous Infusion System K210047Stiletto Extended Dwell Catheter

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

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