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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 the device name listed in this FDA 510(k) record. The listed applicant is Biowy Corporation. It received FDA 510(k) clearance on 2018-05-21 under 510(k) 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. The listed applicant is Biowy Corporation. The 510(k) number is K173956.

When did Biowy PlCC Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Biowy PlCC Catheter?

The FDA 510(k) record lists Biowy Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biowy PlCC Catheter?

The FDA product code for Biowy PlCC Catheter is LJS.

Other records listing Biowy Corporation 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.

K233658Biowy Tym Tube (TT)K192246Biowy PICC Catheter S Kit

Related Devices (Code: LJS)

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.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, 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.

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