Who else makes this device?

Name: Invisiport 4.4 Fr
Brand: Invisiport 4.4 Fr

General Hospital › TherapeuticPort & Catheter, Implanted, Subcutaneous, Intravascular

Invisiport 4.4 Fr

Invisiport 4.4 Fr Convenience Kit Contents: Invisiport 4.4Fr Vascular Access Port with Catheter (Not made with natural rubber latex); Microaccess Tear-Away Introducer Set; MicroIntroducer…

Registry build 21.09.26

Invisiport 4.4 Fr Convenience Kit Contents: Invisiport 4.4Fr Vascular Access Port with Catheter (Not made with natural rubber latex); Microaccess Tear-Away Introducer Set; MicroIntroducer needle; Microguidewire; 20 Gauge, 1.5 inch, Non-Coring Access Needle

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LJT
Manufacturer	City	Province	Registered as	Device types
Turnxon Precision Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	17
Forefront Medical Technology (Jiangsu) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	14

Record

Regulatory record for Invisiport 4.4 Fr
Listed by	Stealth Therapeutics, Incorporated, United States
FDA product code	LJT
Device type	Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class	Class 2
Regulation	21 CFR 880.5965
Record published	2016-03-19
Record revised	2025-08-18 (version 5)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Distribution end date	2018-09-11

Catalogue Numbers

Catalogue numbers for Invisiport 4.4 Fr
Catalogue number	Size	Status
2000		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Dignity®	Medical Components Inc	168
Deltec	ICU Medical, Inc	130
NorPort Vascular Access Port	Norfolk Medical	106
BioFlo Vortex	AngioDynamics, Inc.	60
BioFlo Vortex	Navilyst Medical, Inc.	59
Dignity® MID-Sized CT Port	Medical Components Inc	55
TidalPort Vascular Access Port	Norfolk Medical	52
Pro-Fuse® Low Profile CT Port	Medical Components Inc	45
Dignity® Low Profile CT Port	Medical Components Inc	45
Dignity® Mini CT Port	Medical Components Inc	44
Medcomp GEN III Power Injectable Portmedcomp GEN III Power Injectable Port	Medical Components Inc	29
PRO-Fuse®	Medical Components Inc	28

Showing 12 of 96. All products under Port & Catheter, Implanted, Subcutaneous, Intravascular

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K141146	2015-05-01
K110407	2011-10-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.