MJN · Class II · 21 CFR 870.4450

FDA Product Code MJN: Catheter, Intravascular Occluding, Temporary

Leading manufacturers include Micro Therapeutics, Inc., NuMED, Inc. and MicroVention, Inc..

90
Total
90
Cleared
133d
Avg days
1992
Since
90 devices
25–48 of 90
Cleared Aug 10, 2012
SCEPTER C OCCLUSION BALLOON CATHETER
K121785
MicroVention, Inc.
Cardiovascular · 53d
Cleared Jan 13, 2012
SCEPTER XC OCCLUSION BALLOON CATHETER
K113698
MicroVention, Inc.
Cardiovascular · 28d
Cleared Sep 29, 2011
SCEPTER C OCCLUSION BALLOON CATHETER
K110741
MicroVention, Inc.
Cardiovascular · 197d
Cleared Apr 29, 2011
PTS-X SIZING BALLOON CATHETER
K110903
NuMED, Inc.
Cardiovascular · 29d
Cleared Feb 02, 2010
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
K100063
Ev3, Inc.
Cardiovascular · 22d
Cleared Jan 21, 2010
FOGARTY OCCLUSION CATHETER
K093911
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Apr 16, 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM
K090728
Ev3, Inc.
Cardiovascular · 28d
Cleared Jun 13, 2008
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
K081454
Possis Medical, Inc.
Cardiovascular · 21d
Cleared Jun 29, 2007
GORE BALLOON SHEATH
K070770
W.L. Gore & Associates, Inc.
Cardiovascular · 101d
Cleared Aug 11, 2006
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
K062220
Possis Medical, Inc.
Cardiovascular · 9d
Cleared Jun 10, 2004
NUMED PTS X SIZING BALLOON CATHETER
K041306
NuMED, Inc.
Cardiovascular · 24d
Cleared May 18, 2004
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM
K031357
Possis Medical, Inc.
Cardiovascular · 384d
Cleared Jun 18, 2002
MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
K021066
Micro Therapeutics, Inc.
Cardiovascular · 77d
Cleared Aug 02, 2001
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535
Micro Therapeutics, Inc.
Cardiovascular · 76d
Cleared Jun 20, 2001
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
K011656
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Jun 14, 2001
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
K011526
Micro Therapeutics, Inc.
Cardiovascular · 28d
Cleared May 18, 2001
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
K010162
Micro Therapeutics, Inc.
Cardiovascular · 121d
Cleared May 02, 2001
PTA-OS SIZING BALLOON, MODEL 360
K003320
NuMED, Inc.
Cardiovascular · 190d
Cleared Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
K002286
Cook, Inc.
Cardiovascular · 238d
Cleared May 18, 2000
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
K001237
Micro Therapeutics, Inc.
Cardiovascular · 30d
Cleared Aug 31, 1999
EQUINOX OCCLUSION BALLOON SYSTEM
K990487
Micro Therapeutics, Inc.
Cardiovascular · 196d
Cleared Dec 08, 1992
RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
K915869
Research Medical, Inc.
Cardiovascular · 343d