MJNClass II

Catheter, Intravascular Occluding, Temporary

21 CFR 870.4450 / Cardiovascular

MJN is the FDA product code for Catheter, Intravascular Occluding, Temporary, a class II device type, regulated under 21 CFR 870.4450. As of 2026-09-10, FDA records hold 90 510(k) clearances under this code, the most recent dated 2025-09-05, and 21 recalls.

Classification record

Product code: MJN
Device name: Catheter, Intravascular Occluding, Temporary
Regulation: 21 CFR 870.4450
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 90
Ingested recalls: 21

Clearances, product code MJN

By decision year

90 clearances under product code MJN with a decision year between 1992 and 2025, 2001 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code MJN by decision year
Year	Clearances
1992	1
1996	4
1997	1
1998	1
1999	2
2000	6
2001	7
2002	2
2003	2
2004	3
2005	2
2006	3
2007	2
2008	3
2009	5
2010	5
2011	4
2012	2
2013	4
2014	2
2015	4
2016	3
2017	3
2018	3
2019	3
2020	4
2021	4
2022	2
2023	1
2025	2

Applicants with the most clearances

Product code MJN

Applicants holding the most 510(k) clearances under product code MJN
Applicant	Clearances
Medtronic, Inc.	10
LeMaitre Vascular Inc.	9
Numed Inc	5
Prytime Medical Devices, Inc.	5
RenovoRx, Inc.	4
Boston Scientific Corporation	3
Edwards Lifesciences LLC	3
Terumo Cardiovascular Systems Corporation	3
Micrus Endovascular Corporation	3
Possis Medical, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order