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FDA 510(k)

Biowy PICC Catheter S Kit

K-Number: K192246 · 2020-04-30

ApplicantBiowy Corporation
Decision Date2020-04-30
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biowy PICC Catheter S Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biowy Corporation. It received FDA 510(k) clearance on 2020-04-30 under 510(k) 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. The listed applicant is Biowy Corporation. The 510(k) number is K192246.

When did Biowy PICC Catheter S Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Biowy PICC Catheter S Kit?

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 PICC Catheter S Kit?

The FDA product code for Biowy PICC Catheter S Kit 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)K173956Biowy PlCC Catheter

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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