Polysite Implantable Infusion Ports

Q: What is the product code of K122834?

The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.

FDA 510(k) K122834 · Perouse Medical

Substantially Equivalent

510(k) numberK122834

Submission

Device name: Polysite Implantable Infusion Ports
Applicant: Perouse Medical
France, FR
Received: September 17, 2012
Decision date: December 11, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5965
Specialty: General Hospital
Implant: Yes

Other 510(k)s with product code LJT

510(k)	Device	Applicant	Decision
K260916	FLEXI-PORT Power Injectable Implantable PortLJT · Traditional	Portal Access, Inc.	06/17/2026SE
K252478	Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable…LJT · Special	Bard Access Systems, Inc.	09/05/2025SE
K251253	PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. …LJT · Special	Bard Access Systems, Inc.	06/18/2025SE
K242328	PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable…LJT · Special	Bard Access Systems, Inc.	10/31/2024SE
K232737	PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG…LJT · Special	Bard Peripheral Vascular, Inc.	12/08/2023SE
K190559	SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsLJT · Traditional	AngioDynamics, Inc.	05/22/2020SE
K181446	Bard Power-Injectable Implantable Ports (PowerPorts®)LJT · Traditional	C.R. Bard, Inc.	07/08/2019SE
K151239	Nmi Dual Port IILJT · Traditional	Navilyst Medical, Inc.	06/06/2016SE
K153359	BardPort®, SlimPort®, and X-Port® Implanted PortsLJT · Special	C.R. Bard, Inc.	05/20/2016SE
K153238	Dignity Dual PortLJT · Traditional	Medcomp ( Medical Components)	03/15/2016SE

More from Medcomp ( Medical Components)

510(k)	Device	Decision
K123035	Seal OneDXC · Traditional	11/28/2012SE
K120261	PPS Pi Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS Pi…FPA · Traditional	05/02/2012SE

Questions and answers

When was Polysite Implantable Infusion Ports cleared by the FDA?

Polysite Implantable Infusion Ports (K122834) received a 510(k) decision of Substantially Equivalent on December 11, 2013, 450 days after the submission was received.

What is the product code of K122834?

The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.