MJN · Class II · 21 CFR 870.4450

FDA Product Code MJN: Catheter, Intravascular Occluding, Temporary

Leading manufacturers include LeMaitre Vascular, Inc., Micro Therapeutics, Inc. and NuMED, Inc..

90
Total
90
Cleared
133d
Avg days
1992
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 162d recently vs 133d historically

FDA 510(k) Cleared Catheter, Intravascular Occluding, Temporary Devices (Product Code MJN)

90 devices
1–24 of 90
Cleared Sep 05, 2025
pREBOA-PRO Catheter
K243795
Prytime Medical Devices, Inc.
Cardiovascular · 269d
Cleared Jun 24, 2025
Bridge Plus Occlusion Balloon (590-002)
K251358
Philips Image Guided Therapy Devices
Cardiovascular · 55d
Cleared Jun 30, 2023
preCARDIA Occlusion System
K221294
Abiomed, Inc.
Cardiovascular · 422d
Cleared Sep 19, 2022
LANDMARK REBOA Catheter
K214060
Zien Medical Technologies, Inc.
Cardiovascular · 266d
Cleared Feb 14, 2022
Fogarty Occlusion Catheter
K211610
Edwards Lifesciences, LLC
Cardiovascular · 265d
Cleared Aug 23, 2021
RenovoCath
K212324
Renovorx, Inc.
Cardiovascular · 28d
Cleared Jul 09, 2021
AortaSTAT Occlusion Device
K210602
Renalpro Medical, Inc.
Cardiovascular · 130d
Cleared May 21, 2021
Neurescue device
K210358
Neurescue Aps
Cardiovascular · 102d
Cleared Feb 22, 2021
COBRA-OS Kit
K201652
Front Line Medical Technologies, Inc.
Cardiovascular · 249d
Cleared Dec 23, 2020
Bridge Occlusion Balloon
K203540
Spectranetics, Inc.
Cardiovascular · 20d
Cleared Jun 03, 2020
pREBOA-PRO Catheter
K200459
Prytime Medical Devices, Inc.
Cardiovascular · 99d
Cleared Apr 25, 2020
Gatekeeper Balloon Catheter
K192786
Arch Catheter, LLC
Cardiovascular · 208d
Cleared Jan 09, 2020
ER-REBOA PLUS Catheter
K193440
Prytime Medical Devices, Inc.
Cardiovascular · 29d
Cleared Aug 07, 2019
RenovoCath
K191606
Renovorx, Inc.
Cardiovascular · 51d
Cleared Apr 30, 2019
Eclipse 2L
K183045
Balt USA, LLC
Neurology · 179d
Cleared Apr 24, 2019
Occlusion Balloon Catheter
K183679
Qxmedical, LLC
Cardiovascular · 117d
Cleared Nov 16, 2018
Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
K182916
Lemaitre Vascular
Cardiovascular · 29d
Cleared Jun 08, 2018
Sniper Infusion Catheter with Balloon Occlusion
K180904
Embolx, Inc.
Cardiovascular · 63d
Cleared Jan 31, 2018
GORE Molding and Occlusion Balloon Catheter
K172567
W. L. Gore and Associates, Inc.
Cardiovascular · 159d
Cleared Nov 08, 2017
ER-REBOA Catheter
K172790
Prytime Medical Devices, Inc.
Cardiovascular · 54d
Cleared Apr 04, 2017
ER-REBOA Catheter
K170411
Prytime Medical Devices, Inc.
Cardiovascular · 53d
Cleared Mar 07, 2017
RenovoCath
K160067
Renovorx, Inc.
Cardiovascular · 419d
Cleared Jun 20, 2016
REBOA Balloon Catheter
K160598
NuMED, Inc.
Cardiovascular · 110d
Cleared Feb 05, 2016
Bridge Occlusion Balloon
K153530
Spectranetics, Inc.
Cardiovascular · 58d

About Product Code MJN - Regulatory Context

510(k) Submission Activity

90 total 510(k) submissions under product code MJN since 1992, with 90 receiving FDA clearance (average review time: 133 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MJN Product Code

Recent submissions under MJN have taken an average of 162 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.

MJN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →