Vygon Nutriline and Nutriline Twinflow Catheters

Q: What is the product code of K052475?

The FDA product code is LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5970.

FDA 510(k) K052475 · Vygon Us, LLC

Substantially Equivalent

510(k) numberK052475

Submission

Device name: Vygon Nutriline and Nutriline Twinflow Catheters
Applicant: Vygon Us, LLC
Norristown, PA, US
Received: September 9, 2005
Decision date: September 14, 2006
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5970
Specialty: General Hospital
Implant: Yes

Other 510(k)s with product code LJS

510(k)	Device	Applicant	Decision
K260929	Neonav ECG Tip Location SystemLJS · Special	Navi Medical Technologies	04/17/2026SE
K252373	BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…LJS · Traditional	Spectrum Vascular	12/16/2025SE
K252792	PM2 System with ECGuide ConnectorLJS · Special	Piccolo Medical, Inc.	11/17/2025SE
K243458	HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…LJS · Traditional	Access Vascular, Inc.	08/01/2025SE
K251212	Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…LJS · Special	Access Vascular, Inc.	07/01/2025SE
K243484	PM2+ System and SmartPICC StyletLJS · Traditional	Piccolo Medical, Inc.	05/29/2025SE
K241587	pilot TLSLJS · Traditional	Vygon Corporation	02/26/2025SE
K241910	Neonav ECG Tip Location SystemLJS · Traditional	Navi Medical Technologies	01/19/2025SE
K243941	HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…LJS · Special	Access Vascular, Inc.	01/17/2025SE
K240486	PM2 System and ECGuide ConnectorLJS · Traditional	Piccolo Medical, Inc.	09/08/2024SE

More from Piccolo Medical, Inc.

510(k)	Device	Decision
K033704	Modification to Lumbo-Peritoneal Shunts and Lumbar Drainage CathetersJXG · Special	05/27/2004SE
K040707	Packaging Tray and ComponentsFRG · Special	04/16/2004SE

Questions and answers

When was Vygon Nutriline and Nutriline Twinflow Catheters cleared by the FDA?

Vygon Nutriline and Nutriline Twinflow Catheters (K052475) received a 510(k) decision of Substantially Equivalent on September 14, 2006, 370 days after the submission was received.

What is the product code of K052475?

The FDA product code is LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5970.