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
90 devices
73–90 of 90
Cleared Jan 31, 1997
CHASE VESSEL OCCLUDER
K964390
Chase Medical, Inc.
Cardiovascular · 88d
Cleared Sep 09, 1996
PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
K960715
Ideas For Medicine, Inc.
Cardiovascular · 201d
Cleared Aug 07, 1996
PRUITT SAFETY OCCLUSION CATHETER
K960422
Ideas For Medicine, Inc.
Cardiovascular · 191d
Cleared May 29, 1996
OCCLUSION BALLOON CATHETER
K960832
Interventional Therapeutics Corp.
Cardiovascular · 90d
Cleared Feb 28, 1996
LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER
K955499
Lucas Medical, Inc.
Cardiovascular · 89d
Cleared Dec 08, 1992
RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
K915869
Research Medical, Inc.
Cardiovascular · 343d