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FDA 510(k)

Vygon PICCs

K-Number: K172899 · 2018-02-26

ApplicantVygon USA
Decision Date2018-02-26
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vygon PICCs is the device name listed in this FDA 510(k) record. The listed applicant is Vygon USA. It received FDA 510(k) clearance on 2018-02-26 under 510(k) number K172899. 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 Vygon PICCs?

Vygon PICCs is a medical device that received FDA 510(k) clearance on 2018-02-26. The listed applicant is Vygon USA. The 510(k) number is K172899.

When did Vygon PICCs receive FDA 510(k) clearance?

Vygon PICCs received FDA 510(k) clearance on 2018-02-26, under 510(k) number K172899.

Who is the listed applicant for Vygon PICCs?

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

What is the FDA product code for Vygon PICCs?

The FDA product code for Vygon PICCs is LJS.

Other records listing Vygon USA 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.

K243361NutrifitK212370Leaderflex Mini and Leaderflex NanoK181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL 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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