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 Prytime Medical Devices, Inc..

90
Total
90
Cleared
133d
Avg days
1992
Since
90 devices
49–72 of 90
Cleared Aug 29, 2007
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
K071367
LeMaitre Vascular, Inc.
Cardiovascular · 105d
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 Feb 24, 2006
TECHDEVICE OCCLUSION BALLOON CATHETER
K051137
Techdevice Corporation
Cardiovascular · 296d
Cleared May 27, 2005
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
K051067
LeMaitre Vascular, Inc.
Cardiovascular · 31d
Cleared Dec 03, 2004
PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49
K043023
LeMaitre Vascular, Inc.
Cardiovascular · 30d
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 Dec 19, 2003
LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05
K033159
LeMaitre Vascular, Inc.
Cardiovascular · 80d
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 Jul 21, 2000
CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510
K994141
Medtronic Ave, Inc.
Cardiovascular · 226d
Cleared Jul 12, 2000
AMPLATZER SIZING BALLOON
K993248
Aga Medical Corp.
Cardiovascular · 288d
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 Apr 13, 2000
LEMAITRE OCCLUSION CATHETER
K992942
Vascutech, Inc.
Cardiovascular · 226d
Cleared Mar 23, 2000
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
K993292
Boston Scientific, Target
Cardiovascular · 174d
Cleared Aug 31, 1999
EQUINOX OCCLUSION BALLOON SYSTEM
K990487
Micro Therapeutics, Inc.
Cardiovascular · 196d
Cleared Jul 30, 1999
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB
K983802
Lucas Medical, Inc.
Cardiovascular · 275d
Cleared Mar 11, 1998
TEMPORARY OCCLUSION BALLOON SYSTEM
K972777
Percu Surge, Inc.
Cardiovascular · 229d