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FDA 510(k)

Biowy PlCC Catheter

K-Number: K173956 · 2018-05-21

ApplicantBiowy Corporation
Decision Date2018-05-21
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biowy PlCC Catheter is a medical device manufactured by Biowy Corporation. It received FDA 510(k) clearance on 2018-05-21 under approval number K173956. 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 PlCC Catheter?

Biowy PlCC Catheter is a medical device that received FDA 510(k) clearance on 2018-05-21. It is manufactured by Biowy Corporation. The 510(k) number is K173956.

When was Biowy PlCC Catheter approved by the FDA?

Biowy PlCC Catheter received FDA 510(k) clearance on 2018-05-21, under approval number K173956.

What company makes Biowy PlCC Catheter?

Biowy PlCC Catheter is manufactured by Biowy Corporation.

What is the FDA product code for Biowy PlCC Catheter?

The FDA product code for Biowy PlCC Catheter is LJS.

Other Devices by Biowy Corporation

K192246Biowy PICC Catheter S Kit 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

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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