Panels › Cardiovascular › Product code MJN · Class 2
Catheter, Intravascular Occluding, Temporary
Regulation 870.4450
0510(k)s in 12 months (90 all time)
0recalls in 12 months (21 all time)
20recalls that name a 510(k)
Top companies in MJN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 16, 2009 | K090728 | HYPERGLIDE OCCLUSION BALLOON SYSTEM Ev3, Inc. | MJN |
| Sep 26, 2008 | K080700 | DUOFLO CATHETER Thermopeutix, Inc. | MJN |
| Aug 27, 2008 | K080861 | MICRUS ASCENT OCCLUSION BALLOON CATHETER Micrus Endovascular Corporation | MJN |
| Jun 13, 2008 | K081454 | GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE Possis Medical, Inc. | MJN |
| Aug 29, 2007 | K071367 | FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 LeMaitre Vascular, Inc. | MJN |
| Jun 29, 2007 | K070770 | GORE BALLOON SHEATH W. L. Gore & Associates, Inc. | MJN |
| Aug 11, 2006 | K062220 | MODIFICATION TO GUARDDOG OCCLUSION SYSTEM Possis Medical, Inc. | MJN |
| Mar 20, 2006 | K052844 | KAVS - CATHETER, MODELS 1107100 & 1107060 Richter & Rothe AG, DE | MJN |
| Feb 24, 2006 | K051137 | TECHDEVICE OCCLUSION BALLOON CATHETER Techdevice Corporation | MJN |
| Dec 30, 2005 | K053440 | AMPLATZER SIZING BALLOON II Aga Medical Corp. | MJN |
| May 27, 2005 | K051067 | PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) LeMaitre Vascular, Inc. | MJN |
| Dec 3, 2004 | K043023 | PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 LeMaitre Vascular, Inc. | MJN |
| Jun 10, 2004 | K041306 | NUMED PTS X SIZING BALLOON CATHETER NuMED, Inc. | MJN |
| May 18, 2004 | K031357 | GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM Possis Medical, Inc. | MJN |
| Dec 19, 2003 | K033159 | LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 LeMaitre Vascular, Inc. | MJN |
| Feb 21, 2003 | K023914 | COAXIA FLOCONTROL CATHETER Coaxia, Inc. | MJN |
| Oct 28, 2002 | K021210 | ARTERIA OCCLUSION BALLOON Arteria Medical Science, Inc. | MJN |
| Jun 18, 2002 | K021066 | MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM Micro Therapeutics, Inc. | MJN |
| Aug 2, 2001 | K011535 | CADENCE PRECISION INJECTOR, MODEL 103-0304 Micro Therapeutics, Inc. | MJN |
| Jun 20, 2001 | K011656 | HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 Micro Therapeutics, Inc. | MJN |
| Jun 14, 2001 | K011526 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 Micro Therapeutics, Inc. | MJN |
| Jun 6, 2001 | K001917 | PARODI CATHETER FOR ANGIOGRAPHY (PARCA) Arteria Medical Science, Inc. | MJN |
| May 18, 2001 | K010162 | EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 Micro Therapeutics, Inc. | MJN |
| May 2, 2001 | K003320 | PTA-OS SIZING BALLOON, MODEL 360 NuMED, Inc. | MJN |
| Mar 22, 2001 | K002286 | LDOB OCCLUSION BALLOON CATHETER Cook, Inc. | MJN |
| Dec 6, 2000 | K001621 | DARDIK CAROTID SHUNT Vascutech, Inc. | MJN |
| Jul 21, 2000 | K994141 | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 Medtronic Ave, Inc. | MJN |
| Jul 12, 2000 | K993248 | AMPLATZER SIZING BALLOON Aga Medical Corp. | MJN |
| May 18, 2000 | K001237 | EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO Micro Therapeutics, Inc. | MJN |
| Apr 13, 2000 | K992942 | LEMAITRE OCCLUSION CATHETER Vascutech, Inc. | MJN |
| Mar 23, 2000 | K993292 | BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER Boston Scientific, Target | MJN |
| Aug 31, 1999 | K990487 | EQUINOX OCCLUSION BALLOON SYSTEM Micro Therapeutics, Inc. | MJN |
| Jul 30, 1999 | K983802 | LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB Lucas Medical, Inc. | MJN |
| Mar 11, 1998 | K972777 | TEMPORARY OCCLUSION BALLOON SYSTEM Percu Surge, Inc. | MJN |
| Jan 31, 1997 | K964390 | CHASE VESSEL OCCLUDER Chase Medical, Inc. | MJN |
| Sep 9, 1996 | K960715 | PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F Ideas For Medicine, Inc. | MJN |
| Aug 7, 1996 | K960422 | PRUITT SAFETY OCCLUSION CATHETER Ideas For Medicine, Inc. | MJN |
| May 29, 1996 | K960832 | OCCLUSION BALLOON CATHETER Interventional Therapeutics Corp. | MJN |
| Feb 28, 1996 | K955499 | LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER Lucas Medical, Inc. | MJN |
| Dec 8, 1992 | K915869 | RMI NORMOCLUDER CORONARY ARTERY OCCLUDER Research Medical, Inc. | MJN |
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