FDA 510(k)

Biowy PICC Catheter S Kit

K-Number: K192246 · 2020-04-30

Decision Date2020-04-30

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Biowy PICC Catheter S Kit is a medical device manufactured by Biowy Corporation. It received FDA 510(k) clearance on 2020-04-30 under approval number K192246. 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 Biowy PICC Catheter S Kit?

Biowy PICC Catheter S Kit is a medical device that received FDA 510(k) clearance on 2020-04-30. It is manufactured by Biowy Corporation. The 510(k) number is K192246.

When was Biowy PICC Catheter S Kit approved by the FDA?

Biowy PICC Catheter S Kit received FDA 510(k) clearance on 2020-04-30, under approval number K192246.

What company makes Biowy PICC Catheter S Kit?

Biowy PICC Catheter S Kit is manufactured by Biowy Corporation.

What is the FDA product code for Biowy PICC Catheter S Kit?

The FDA product code for Biowy PICC Catheter S Kit is LJS.

Other Devices by Biowy Corporation

K173956Biowy PlCC Catheter K233658Biowy Tym Tube (TT)

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.