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FDA 510(k)

pilot TLS

K-Number: K241587 · 2025-02-26

ApplicantVygon Corporation
Decision Date2025-02-26
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

pilot TLS is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corporation. It received FDA 510(k) clearance on 2025-02-26 under 510(k) number K241587. 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 pilot TLS?

pilot TLS is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is Vygon Corporation. The 510(k) number is K241587.

When did pilot TLS receive FDA 510(k) clearance?

pilot TLS received FDA 510(k) clearance on 2025-02-26, under 510(k) number K241587.

Who is the listed applicant for pilot TLS?

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

What is the FDA product code for pilot TLS?

The FDA product code for pilot TLS is LJS.

Other records listing Vygon 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.

K151237Nutrisafe 2- ENFit Adaptor

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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