FDA 510(k)

VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS

K-Number: K052475 · 2006-09-14

Decision Date2006-09-14

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Us, LLC. It received FDA 510(k) clearance on 2006-09-14 under 510(k) number K052475. 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 NUTRILINE AND NUTRILINE TWINFLOW CATHETERS?

VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS is a medical device that received FDA 510(k) clearance on 2006-09-14. The listed applicant is Vygon Us, LLC. The 510(k) number is K052475.

When did VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS receive FDA 510(k) clearance?

VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS received FDA 510(k) clearance on 2006-09-14, under 510(k) number K052475.

Who is the listed applicant for VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS?

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

What is the FDA product code for VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS?

The FDA product code for VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS is LJS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vygon Us, LLC as applicant

K033704MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS K040707PACKAGING TRAY AND COMPONENTS

Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo 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 Vascular K252792PM2™ 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.