Catheter, Intravascular Occluding, Temporary

K number K243795

MJN 2025-06-24

Bridge Plus Occlusion Balloon (590-002)

Applicant Philips Image Guided Therapy Devices

K number K251358

MJN 2023-06-30

preCARDIA Occlusion System

Applicant Abiomed, Inc.

K number K221294

MJN 2022-09-19

LANDMARK REBOA Catheter

Applicant Zien Medical Technologies, Inc.

K number K214060

MJN 2022-02-14

Fogarty Occlusion Catheter

Applicant Edwards Lifesciences, LLC

K number K211610

MJN 2021-08-23

RenovoCath

Applicant Renovorx, Inc.

K number K212324

MJN 2021-07-09

AortaSTAT Occlusion Device

Applicant Renalpro Medical, Inc.

K number K210602

MJN 2021-05-21

Neurescue device

Applicant Neurescue Aps

K number K210358

MJN 2021-02-22

COBRA-OS Kit

Applicant Front Line Medical Technologies, Inc.

K number K201652

MJN 2020-12-23

Bridge Occlusion Balloon

Applicant Spectranetics, Inc.

K number K203540

MJN 2020-06-03

pREBOA-PRO Catheter

K number K200459

MJN 2020-04-25

Gatekeeper Balloon Catheter

Applicant Arch Catheter, LLC

K number K192786

MJN 2020-01-09

ER-REBOA PLUS Catheter

K number K193440

MJN 2019-08-07

RenovoCath

Applicant Renovorx, Inc.

K number K191606

MJN 2019-04-30

Eclipse 2L

Applicant Balt USA, LLC

K number K183045

MJN 2019-04-24

Occlusion Balloon Catheter

Applicant Qxmedical, LLC

K number K183679

MJN 2018-11-16

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr

Applicant Lemaitre Vascular

K number K182916

MJN 2018-06-08

Sniper Infusion Catheter with Balloon Occlusion

Applicant Embolx, Inc.

K number K180904

MJN 2018-01-31

GORE Molding and Occlusion Balloon Catheter

Applicant W. L. Gore and Associates, Inc.

K number K172567

MJN 2017-11-08

ER-REBOA Catheter

K number K172790

MJN 2017-04-04

ER-REBOA Catheter

K number K170411

MJN 2017-03-07

RenovoCath

Applicant Renovorx, Inc.

K number K160067

MJN 2016-06-20

REBOA Balloon Catheter

Applicant NuMED, Inc.

K number K160598

MJN 2016-02-05

Bridge Occlusion Balloon

Applicant Spectranetics, Inc.

K number K153530

MJN 2016-01-21

Pruitt F3-S Polyurethane Carotid Shunt

Applicant LeMaitre Vascular, Inc.

K number K152833

MJN 2013-11-06

LEMAITRE 8F OCCLUSION CATHETER

Applicant LeMaitre Vascular, Inc.

K number K132022

MJN 2013-10-22

OCCLUSION BALLOON CATHETER

Applicant Boston Scientific Corp

K number K132990

MJN 2013-08-08

PTS-X SIZING BALLOON CATHETER

Applicant NuMED, Inc.

K number K131869

MJN 2013-01-11

TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT

Applicant Stryker Neurovascular

K number K122576

MJN 2012-08-10

SCEPTER C OCCLUSION BALLOON CATHETER

Applicant MicroVention, Inc.

K number K121785

MJN 2012-01-13

SCEPTER XC OCCLUSION BALLOON CATHETER

Applicant MicroVention, Inc.

K number K113698

MJN 2011-11-18

TAPAS CATHETER

Applicant Thermopeutix, Inc.

K number K112219

MJN 2011-09-29

SCEPTER C OCCLUSION BALLOON CATHETER

Applicant MicroVention, Inc.

K number K110741

MJN 2011-04-29

PTS-X SIZING BALLOON CATHETER

Applicant NuMED, Inc.

K number K110903

MJN 2011-01-26

MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO

Applicant Micrus Endovascular Corporation

K number K103780

MJN 2010-12-08

PRUITT CAROTID KIT

Applicant LeMaitre Vascular, Inc.

K number K103356

MJN 2010-08-25

DUFLO CATHETER (HEPARIN COATED)

Applicant Thermopeutix, Inc.

K number K093847

MJN 2010-07-13

HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS

Applicant Micro Therapeutics Dba Ev3 Neurovascular

K number K101570

MJN 2010-02-02

HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL

Applicant Ev3, Inc.

K number K100063

MJN 2010-01-21

FOGARTY OCCLUSION CATHETER

Applicant Edwards Lifesciences, LLC

K number K093911

MJN 2009-10-15

HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104

Applicant Ev3 Neurovascular

K number K091458

MJN 2009-09-22

HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

Applicant Ev3 Neurovascular

K number K092495

MJN 2009-06-19

MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00

Applicant Micrus Endovascular Corporation

K number K091504

MJN 2009-06-12

FLOCONTROL , MODEL 1028

Applicant Coaxia, Inc.

K number K090970

MJN 2009-04-16

HYPERGLIDE OCCLUSION BALLOON SYSTEM

Applicant Ev3, Inc.

K number K090728

MJN 2008-09-26

DUOFLO CATHETER

Applicant Thermopeutix, Inc.

K number K080700

MJN 2008-08-27

MICRUS ASCENT OCCLUSION BALLOON CATHETER

Applicant Micrus Endovascular Corporation

K number K080861

MJN 2008-06-13

GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE

Applicant Possis Medical, Inc.

K number K081454

MJN 2007-08-29

FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05

Applicant LeMaitre Vascular, Inc.

K number K071367

MJN 2007-06-29

GORE BALLOON SHEATH

Applicant W. L. Gore & Associates, Inc.

K number K070770

MJN 2006-08-11

MODIFICATION TO GUARDDOG OCCLUSION SYSTEM

Applicant Possis Medical, Inc.

K number K062220

MJN 2006-03-20

KAVS - CATHETER, MODELS 1107100 & 1107060

Applicant Richter & Rothe AG

K number K052844

MJN 2006-02-24

TECHDEVICE OCCLUSION BALLOON CATHETER

Applicant Techdevice Corporation

K number K051137

MJN 2005-12-30

AMPLATZER SIZING BALLOON II

Applicant Aga Medical Corp.

K number K053440

MJN 2005-05-27

PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)

Applicant LeMaitre Vascular, Inc.

K number K051067

MJN 2004-12-03

PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49

Applicant LeMaitre Vascular, Inc.

K number K043023

MJN 2004-06-10

NUMED PTS X SIZING BALLOON CATHETER

Applicant NuMED, Inc.

K number K041306

MJN 2004-05-18

GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM

Applicant Possis Medical, Inc.

K number K031357

MJN 2003-12-19

LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05

Applicant LeMaitre Vascular, Inc.

K number K033159

MJN 2003-02-21

COAXIA FLOCONTROL CATHETER

Applicant Coaxia, Inc.

K number K023914

MJN 2002-10-28

ARTERIA OCCLUSION BALLOON

Applicant Arteria Medical Science, Inc.

K number K021210

MJN 2002-06-18

MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM

K number K021066

MJN 2001-08-02

CADENCE PRECISION INJECTOR, MODEL 103-0304

K number K011535

MJN 2001-06-20

HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771

K number K011656

MJN 2001-06-14

HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123

K number K011526

MJN 2001-06-06

PARODI CATHETER FOR ANGIOGRAPHY (PARCA)

Applicant Arteria Medical Science, Inc.

K number K001917

MJN 2001-05-18

EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026

K number K010162

MJN 2001-05-02

PTA-OS SIZING BALLOON, MODEL 360

Applicant NuMED, Inc.

K number K003320

MJN 2001-03-22

LDOB OCCLUSION BALLOON CATHETER

Applicant Cook, Inc.

K number K002286

MJN 2000-12-06

DARDIK CAROTID SHUNT

Applicant Vascutech, Inc.

K number K001621