LJTClass II

Port & Catheter, Implanted, Subcutaneous, Intravascular

21 CFR 880.5965 / General Hospital

LJT is the FDA product code for Port & Catheter, Implanted, Subcutaneous, Intravascular, a class II device type, regulated under 21 CFR 880.5965. As of 2026-09-10, FDA records hold 288 510(k) clearances under this code, the most recent dated 2026-06-17, and 141 recalls.

Classification record

Product code: LJT
Device name: Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation: 21 CFR 880.5965
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 288
Ingested recalls: 141

Clearances, product code LJT

By decision year

288 clearances under product code LJT with a decision year between 1983 and 2026, 1995 the highest year at 28.

Show the numbers

510(k) clearances under FDA product code LJT by decision year
Year	Clearances
1983	5
1984	6
1985	5
1986	9
1987	18
1988	12
1989	6
1990	9
1991	27
1992	7
1993	9
1994	27
1995	28
1996	16
1997	8
1998	8
1999	4
2000	7
2001	3
2002	2
2003	12
2004	2
2005	2
2006	4
2007	11
2008	7
2009	2
2010	2
2011	5
2012	2
2013	7
2014	2
2015	4
2016	3
2019	1
2020	1
2023	1
2024	1
2025	2
2026	1

Applicants with the most clearances

Product code LJT

Applicants holding the most 510(k) clearances under product code LJT
Applicant	Clearances
Boston Scientific Corporation	29
Strato Medical Corp.	27
Therex Corp.	24
C.R. Bard Inc	22
Med Institute, Inc.	17
Norfolk Medical Products, Inc.	14
Sims Deltec, Inc.	10
Arrow Intl., Inc.	8
Pharmacia Deltec, Inc.	7
Bard Access Systems, Inc.	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order