Product Code: MJN FDA class 2 21 CFR 870.4450

Catheter, Intravascular Occluding, Temporary

Cardiovascular

The Temporary Intravascular Occluding Balloon Catheter is a catheter with an inflatable balloon at its tip used to temporarily occlude blood flow in a blood vessel during surgical or endovascular procedures, controlling hemorrhage or isolating vascular territories for treatment. Classified as a Class 2 device under 21 CFR 870.4450 within the Cardiovascular specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code MJN in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: MJN
Device Class: FDA class 2
Regulation Number: 870.4450
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 90 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243795	pREBOA-PRO Catheter	Sep 05, 2025	Substantially Equivalent	Prytime Medical Devices, Inc.
K251358	Bridge Plus Occlusion Balloon (590-002)	Jun 24, 2025	Substantially Equivalent	Philips Image Guided Therapy Devices
K221294	preCARDIA Occlusion System	Jun 30, 2023	Unknown	Abiomed, Inc.
K214060	LANDMARK REBOA Catheter	Sep 19, 2022	Substantially Equivalent	Zien Medical Technologies, Inc.
K211610	Fogarty Occlusion Catheter	Feb 14, 2022	Substantially Equivalent	Edwards Lifesciences, LLC
K212324	RenovoCath	Aug 23, 2021	Substantially Equivalent	Renovorx, Inc.
K210602	AortaSTAT Occlusion Device	Jul 09, 2021	Substantially Equivalent	Renalpro Medical, Inc.
K210358	Neurescue device	May 21, 2021	Substantially Equivalent	Neurescue Aps
K201652	COBRA-OS Kit	Feb 22, 2021	Unknown	Front Line Medical Technologies, Inc.
K203540	Bridge Occlusion Balloon	Dec 23, 2020	Substantially Equivalent	Spectranetics, Inc.
K200459	pREBOA-PRO Catheter	Jun 03, 2020	Substantially Equivalent	Prytime Medical Devices, Inc.
K192786	Gatekeeper Balloon Catheter	Apr 25, 2020	Substantially Equivalent	Arch Catheter, LLC
K193440	ER-REBOA PLUS Catheter	Jan 09, 2020	Substantially Equivalent	Prytime Medical Devices, Inc.
K191606	RenovoCath	Aug 07, 2019	Substantially Equivalent	Renovorx, Inc.
K183045	Eclipse 2L	Apr 30, 2019	Substantially Equivalent	Balt USA, LLC
K183679	Occlusion Balloon Catheter	Apr 24, 2019	Substantially Equivalent	Qxmedical, LLC
K182916	Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr	Nov 16, 2018	Substantially Equivalent	Lemaitre Vascular
K180904	Sniper Infusion Catheter with Balloon Occlusion	Jun 08, 2018	Substantially Equivalent	Embolx, Inc.
K172567	GORE Molding and Occlusion Balloon Catheter	Jan 31, 2018	Substantially Equivalent	W. L. Gore and Associates, Inc.
K172790	ER-REBOA Catheter	Nov 08, 2017	Substantially Equivalent	Prytime Medical Devices, Inc.
K170411	ER-REBOA Catheter	Apr 04, 2017	Substantially Equivalent	Prytime Medical Devices, Inc.
K160067	RenovoCath	Mar 07, 2017	Substantially Equivalent	Renovorx, Inc.
K160598	REBOA Balloon Catheter	Jun 20, 2016	Substantially Equivalent	NuMED, Inc.
K153530	Bridge Occlusion Balloon	Feb 05, 2016	Substantially Equivalent	Spectranetics, Inc.
K152833	Pruitt F3-S Polyurethane Carotid Shunt	Jan 21, 2016	Substantially Equivalent	LeMaitre Vascular, Inc.
K152762	Fogarty Occlusion Catheter	Nov 23, 2015	Substantially Equivalent	Edwards Lifesciences, LLC
K143454	Pruitt F3-S Carotid Shunt	Aug 27, 2015	Substantially Equivalent	LeMaitre Vascular, Inc.
K143613	PaxWire Occlusion Balloon System	Aug 14, 2015	Substantially Equivalent	Accessclosure, Inc.
K142692	Occlusion Balloon Catheter	May 31, 2015	Substantially Equivalent	Embolx, Inc.
K141175	RENOVOCATH RC120	Oct 24, 2014	Substantially Equivalent	Renovorx, Inc.
K140273	EQUALIZER OCCLUSION BALLOON CATHETER	Jul 22, 2014	Substantially Equivalent	Boston Scientific Corp
K132022	LEMAITRE 8F OCCLUSION CATHETER	Nov 06, 2013	Substantially Equivalent	LeMaitre Vascular, Inc.
K132990	OCCLUSION BALLOON CATHETER	Oct 22, 2013	Substantially Equivalent	Boston Scientific Corp
K131869	PTS-X SIZING BALLOON CATHETER	Aug 08, 2013	Substantially Equivalent	NuMED, Inc.
K122576	TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT	Jan 11, 2013	Substantially Equivalent	Stryker Neurovascular
K121785	SCEPTER C OCCLUSION BALLOON CATHETER	Aug 10, 2012	Substantially Equivalent	MicroVention, Inc.
K113698	SCEPTER XC OCCLUSION BALLOON CATHETER	Jan 13, 2012	Substantially Equivalent	MicroVention, Inc.
K112219	TAPAS CATHETER	Nov 18, 2011	Substantially Equivalent	Thermopeutix, Inc.
K110741	SCEPTER C OCCLUSION BALLOON CATHETER	Sep 29, 2011	Substantially Equivalent	MicroVention, Inc.
K110903	PTS-X SIZING BALLOON CATHETER	Apr 29, 2011	Substantially Equivalent	NuMED, Inc.
K103780	MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO	Jan 26, 2011	Substantially Equivalent	Micrus Endovascular Corporation
K103356	PRUITT CAROTID KIT	Dec 08, 2010	Substantially Equivalent	LeMaitre Vascular, Inc.
K093847	DUFLO CATHETER (HEPARIN COATED)	Aug 25, 2010	Substantially Equivalent	Thermopeutix, Inc.
K101570	HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS	Jul 13, 2010	Substantially Equivalent	Micro Therapeutics Dba Ev3 Neurovascular
K100063	HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL	Feb 02, 2010	Substantially Equivalent	Ev3, Inc.
K093911	FOGARTY OCCLUSION CATHETER	Jan 21, 2010	Substantially Equivalent	Edwards Lifesciences, LLC
K091458	HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104	Oct 15, 2009	Substantially Equivalent	Ev3 Neurovascular
K092495	HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315	Sep 22, 2009	Substantially Equivalent	Ev3 Neurovascular
K091504	MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00	Jun 19, 2009	Substantially Equivalent	Micrus Endovascular Corporation
K090970	FLOCONTROL , MODEL 1028	Jun 12, 2009	Substantially Equivalent	Coaxia, Inc.
K090728	HYPERGLIDE OCCLUSION BALLOON SYSTEM	Apr 16, 2009	Substantially Equivalent	Ev3, Inc.
K080700	DUOFLO CATHETER	Sep 26, 2008	Substantially Equivalent	Thermopeutix, Inc.
K080861	MICRUS ASCENT OCCLUSION BALLOON CATHETER	Aug 27, 2008	Substantially Equivalent	Micrus Endovascular Corporation
K081454	GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE	Jun 13, 2008	Substantially Equivalent	Possis Medical, Inc.
K071367	FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05	Aug 29, 2007	Substantially Equivalent	LeMaitre Vascular, Inc.
K070770	GORE BALLOON SHEATH	Jun 29, 2007	Substantially Equivalent	W. L. Gore & Associates, Inc.
K062220	MODIFICATION TO GUARDDOG OCCLUSION SYSTEM	Aug 11, 2006	Substantially Equivalent	Possis Medical, Inc.
K052844	KAVS - CATHETER, MODELS 1107100 & 1107060	Mar 20, 2006	Substantially Equivalent	Richter & Rothe AG
K051137	TECHDEVICE OCCLUSION BALLOON CATHETER	Feb 24, 2006	Substantially Equivalent	Techdevice Corporation
K053440	AMPLATZER SIZING BALLOON II	Dec 30, 2005	Substantially Equivalent	Aga Medical Corp.
K051067	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	May 27, 2005	Substantially Equivalent	LeMaitre Vascular, Inc.
K043023	PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49	Dec 03, 2004	Substantially Equivalent	LeMaitre Vascular, Inc.
K041306	NUMED PTS X SIZING BALLOON CATHETER	Jun 10, 2004	Substantially Equivalent	NuMED, Inc.
K031357	GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM	May 18, 2004	Substantially Equivalent	Possis Medical, Inc.
K033159	LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05	Dec 19, 2003	Substantially Equivalent	LeMaitre Vascular, Inc.
K023914	COAXIA FLOCONTROL CATHETER	Feb 21, 2003	Substantially Equivalent	Coaxia, Inc.
K021210	ARTERIA OCCLUSION BALLOON	Oct 28, 2002	Substantially Equivalent	Arteria Medical Science, Inc.
K021066	MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM	Jun 18, 2002	Substantially Equivalent	Micro Therapeutics, Inc.
K011535	CADENCE PRECISION INJECTOR, MODEL 103-0304	Aug 02, 2001	Substantially Equivalent	Micro Therapeutics, Inc.
K011656	HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771	Jun 20, 2001	Substantially Equivalent	Micro Therapeutics, Inc.
K011526	HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123	Jun 14, 2001	Substantially Equivalent	Micro Therapeutics, Inc.
K001917	PARODI CATHETER FOR ANGIOGRAPHY (PARCA)	Jun 06, 2001	Substantially Equivalent	Arteria Medical Science, Inc.
K010162	EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026	May 18, 2001	Substantially Equivalent	Micro Therapeutics, Inc.
K003320	PTA-OS SIZING BALLOON, MODEL 360	May 02, 2001	Substantially Equivalent	NuMED, Inc.
K002286	LDOB OCCLUSION BALLOON CATHETER	Mar 22, 2001	Substantially Equivalent	Cook, Inc.
K001621	DARDIK CAROTID SHUNT	Dec 06, 2000	Substantially Equivalent	Vascutech, Inc.
K994141	CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000	Jul 21, 2000	Substantially Equivalent	Medtronic Ave, Inc.
K993248	AMPLATZER SIZING BALLOON	Jul 12, 2000	Substantially Equivalent	Aga Medical Corp.
K001237	EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO	May 18, 2000	Substantially Equivalent	Micro Therapeutics, Inc.
K992942	LEMAITRE OCCLUSION CATHETER	Apr 13, 2000	Substantially Equivalent	Vascutech, Inc.
K993292	BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER	Mar 23, 2000	Substantially Equivalent	Boston Scientific, Target
K990487	EQUINOX OCCLUSION BALLOON SYSTEM	Aug 31, 1999	Unknown	Micro Therapeutics, Inc.
K983802	LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB	Jul 30, 1999	Substantially Equivalent	Lucas Medical, Inc.
K972777	TEMPORARY OCCLUSION BALLOON SYSTEM	Mar 11, 1998	Unknown	Percu Surge, Inc.
K964390	CHASE VESSEL OCCLUDER	Jan 31, 1997	Substantially Equivalent	Chase Medical, Inc.
K960715	PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F	Sep 09, 1996	Substantially Equivalent	Ideas For Medicine, Inc.
K960422	PRUITT SAFETY OCCLUSION CATHETER	Aug 07, 1996	Substantially Equivalent	Ideas For Medicine, Inc.
K960832	OCCLUSION BALLOON CATHETER	May 29, 1996	Substantially Equivalent	Interventional Therapeutics Corp.
K955499	LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER	Feb 28, 1996	Substantially Equivalent	Lucas Medical, Inc.
K915869	RMI NORMOCLUDER CORONARY ARTERY OCCLUDER	Dec 08, 1992	Substantially Equivalent	Research Medical, Inc.