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
25–48 of 90
Cleared Jan 21, 2016
Pruitt F3-S Polyurethane Carotid Shunt
K152833
LeMaitre Vascular, Inc.
Cardiovascular · 114d
Cleared Nov 23, 2015
Fogarty Occlusion Catheter
K152762
Edwards Lifesciences, LLC
Cardiovascular · 60d
Cleared Aug 27, 2015
Pruitt F3-S Carotid Shunt
K143454
LeMaitre Vascular, Inc.
Cardiovascular · 267d
Cleared Aug 14, 2015
PaxWire Occlusion Balloon System
K143613
Accessclosure, Inc.
Cardiovascular · 238d
Cleared May 31, 2015
Occlusion Balloon Catheter
K142692
Embolx, Inc.
Cardiovascular · 251d
Cleared Oct 24, 2014
RENOVOCATH RC120
K141175
Renovorx, Inc.
Cardiovascular · 171d
Cleared Jul 22, 2014
EQUALIZER OCCLUSION BALLOON CATHETER
K140273
Boston Scientific Corp
Cardiovascular · 169d
Cleared Nov 06, 2013
LEMAITRE 8F OCCLUSION CATHETER
K132022
LeMaitre Vascular, Inc.
Cardiovascular · 128d
Cleared Oct 22, 2013
OCCLUSION BALLOON CATHETER
K132990
Boston Scientific Corp
Cardiovascular · 28d
Cleared Aug 08, 2013
PTS-X SIZING BALLOON CATHETER
K131869
NuMED, Inc.
Cardiovascular · 45d
Cleared Jan 11, 2013
TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
K122576
Stryker Neurovascular
Cardiovascular · 141d
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 Nov 18, 2011
TAPAS CATHETER
K112219
Thermopeutix, Inc.
Cardiovascular · 108d
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 Jan 26, 2011
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM
K103780
Micrus Endovascular Corporation
Cardiovascular · 30d
Cleared Dec 08, 2010
PRUITT CAROTID KIT
K103356
LeMaitre Vascular, Inc.
General & Plastic Surgery · 22d
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 Jun 19, 2009
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00
K091504
Micrus Endovascular Corporation
Cardiovascular · 29d
Cleared Apr 16, 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM
K090728
Ev3, Inc.
Cardiovascular · 28d
Cleared Aug 27, 2008
MICRUS ASCENT OCCLUSION BALLOON CATHETER
K080861
Micrus Endovascular Corporation
Cardiovascular · 153d
Cleared Jun 13, 2008
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
K081454
Possis Medical, Inc.
Cardiovascular · 21d