Trimport

FDA 510(k) K974533 · Gerard Medical, Inc.

Substantially Equivalent

510(k) numberK974533

Submission

Device name
Trimport
Applicant
Gerard Medical, Inc.
Charlton City, MA, US
Received
December 2, 1997
Decision date
May 7, 1998
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)DeviceApplicantDecision
K260916FLEXI-PORT™ Power Injectable Implantable PortLJT · Traditional Portal Access, Inc.06/17/2026SE
K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable…LJT · Special Bard Access Systems, Inc.09/05/2025SE
K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™…LJT · Special Bard Access Systems, Inc.06/18/2025SE
K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…LJT · Special Bard Access Systems, Inc.10/31/2024SE
K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG…LJT · Special Bard Peripheral Vascular, Inc.12/08/2023SE
K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsLJT · Traditional AngioDynamics, Inc.05/22/2020SE
K181446Bard Power-Injectable Implantable Ports (PowerPorts®)LJT · Traditional C.R. Bard, Inc.07/08/2019SE
K151239Nmi Dual Port IILJT · Traditional Navilyst Medical, Inc.06/06/2016SE
K153359BardPort®, SlimPort®, and X-Port® Implanted PortsLJT · Special C.R. Bard, Inc.05/20/2016SE
K153238Dignity Dual PortLJT · Traditional Medcomp ( Medical Components)03/15/2016SE

More from Medcomp ( Medical Components)

510(k)DeviceDecision
K972555Catheter TunnelerLJS · Traditional 12/22/1997SE
K945060Hernia Mesh Introduction SystemFTL · Traditional 03/02/1995SE
K936207Endo-Needle InstrumentGDM · Traditional 06/16/1994SE

Questions and answers

When was Trimport cleared by the FDA?

Trimport (K974533) received a 510(k) decision of Substantially Equivalent on May 7, 1998, 156 days after the submission was received.

What is the product code of K974533?

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