Product Code: KRD FDA class 2 21 CFR 870.3300

Device, Vascular, For Promoting Embolization

Cardiovascular

This device is a vascular device used to promote embolization, which involves intentionally occluding blood vessels to treat conditions such as arteriovenous malformations, aneurysms, tumor vascularity, or hemorrhage through interventional radiology or vascular surgery. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRD, regulated under 21 CFR 870.3300 within the Cardiovascular specialty. This device is designated as an implant, as it is placed within the vascular system.

View on FDA

510(k)s

129

FEI Numbers

103

Registration Numbers

103

Unique Applicants

Years Active

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Basic Information

Product Code: KRD
Device Class: FDA class 2
Regulation Number: 870.3300
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 129 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260635	HARBOR Occlusion Device	Jun 12, 2026	Substantially Equivalent	Nuvascular, Inc.
K260508	LOBO Vascular Occlusion System	Apr 10, 2026	Substantially Equivalent	Okami Medical, Inc.
K253511	Concerto Versa Detachable Coil	Jan 14, 2026	Substantially Equivalent	Medtronic, Inc.
K253677	Tembo Embolic System	Dec 15, 2025	Substantially Equivalent	Instylla, Inc.
K253376	OBSIDIO Conformable Embolic (M0013972101010)	Oct 30, 2025	Substantially Equivalent	Boston Scientific Corporation
K250209	Polyvinyl Alcohol Embolic Microspheres	Sep 23, 2025	Substantially Equivalent	Canyon Medical, Inc.
K250133	HARBOR Occlusion Device	Jul 09, 2025	Substantially Equivalent	Nuvascular, Inc.
K251383	Prestige Coil System (Prestige Packing Line Extension)	May 30, 2025	Substantially Equivalent	Balt USA, LLC
K250971	Embosphere Microspheres	May 16, 2025	Substantially Equivalent	Biosphere Medical, S.A.
K250276	Nitinol Enhanced Device (NED)	May 15, 2025	Substantially Equivalent	Embolization, Inc.
K250079	Ruby XL System	Mar 14, 2025	Substantially Equivalent	Penumbra, Inc.
K242608	Embozene Color-Advanced Microspheres	Jan 17, 2025	Substantially Equivalent	Varian Medical Systems, Inc.
K240873	TEMBO Embolic System	Dec 16, 2024	Substantially Equivalent	Instylla, Inc.
K242794	ONCOZENE Microspheres	Oct 16, 2024	Substantially Equivalent	Varian Medical Systems, Inc.
K242507	OBSIDIO Conformable Embolic	Oct 03, 2024	Substantially Equivalent	Boston Scientific
K232934	Sunsphere	May 30, 2024	Substantially Equivalent	Hangzhou Yangshun Medical Technology Co.,Ltd
K240261	Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)	May 02, 2024	Substantially Equivalent	Merit Medical Systems, Inc.
K234123	Easi-Vue® embolic microspheres System	Feb 13, 2024	Substantially Equivalent	Abk Biomedical, Inc.
K231554	UniPearls® Embolic Microspheres	Nov 14, 2023	Substantially Equivalent	Suzhou Haowei Medical Technology Co., Ltd.
K230706	EMBOLD Soft Detachable Coil System	Jun 27, 2023	Substantially Equivalent	Boston Scientific Corporation
K223050	AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)	Dec 21, 2022	Substantially Equivalent	MicroVention, Inc.
K220567	Easi-Vue embolic microspheres System	Sep 07, 2022	Substantially Equivalent	Abk Biomedical, Inc.
K213385	GEM	Jul 01, 2022	Substantially Equivalent	Obsidio, Inc.
K220383	LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)	Apr 29, 2022	Substantially Equivalent	Okami Medical
K213398	EMBOLD Fibered Detachable Coil System	Apr 12, 2022	Substantially Equivalent	Boston Scientific Corporation
K220699	Prestige Coil System	Apr 08, 2022	Substantially Equivalent	Bait USA, LLC
K213200	Solus Gold Embolization Device	Mar 21, 2022	Substantially Equivalent	Artio Medical, Inc.
K212057	Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS	Mar 01, 2022	Substantially Equivalent	Artventive Medical Group, Inc.
K212817	Merit Siege Vascular Plug	Dec 15, 2021	Substantially Equivalent	Merit Medical System, Inc.
K210562	HRSpheres Narrow-Size Embolic Microspheres	Oct 01, 2021	Substantially Equivalent	Suzhou Hengrui Hongyuan Medical Co., Ltd.
K202850	Concerto Versa, Detachable Coil	Feb 09, 2021	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K203025	LOBO Vascular Occlusion System (model LOBO-5)	Nov 05, 2020	Substantially Equivalent	Okami Medical
K191680	AZUR Vascular Plug	Mar 20, 2020	Substantially Equivalent	MicroVention, Inc.
K200083	EMBA Hourglass Peripheral Embolization Device (PED)	Feb 14, 2020	Substantially Equivalent	Embolic Acceleration, LLC
K191532	The Caterpillar and Caterpillar Micro Arterial Embolization Devices	Feb 04, 2020	Substantially Equivalent	C.R. Bard, Inc.
K192480	Torpedo Gelatin Foam	Nov 21, 2019	Substantially Equivalent	Biosphere Medical, S.A.
K192083	Okami Medical LOBO Vascular Occlusion System	Oct 30, 2019	Substantially Equivalent	Okami Medical
K183120	EmboCube Embolization Gelatin	Aug 06, 2019	Substantially Equivalent	Biosphere Medical, S.A.
K183578	Torpedo Gelatin Foam	Jun 18, 2019	Substantially Equivalent	Biosphere Medical, S.A.
K182390	IMPEDE-FX Embolization Plug	May 23, 2019	Substantially Equivalent	Shape Memory Medical
K182944	Dr. Amplatz Micro Plug	Apr 17, 2019	Substantially Equivalent	Ka Medical, LLC
K181021	EmboCube Embolization Gelatin	Sep 27, 2018	Substantially Equivalent	Biosphere Medical, S.A.
K181300	Embosphere Microspheres	Jul 16, 2018	Substantially Equivalent	Biosphere Medical, S.A.
K181051	IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm	Jun 22, 2018	Substantially Equivalent	Shape Memory Medical
K173891	Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume	Jan 19, 2018	Substantially Equivalent	Vascular Solutions, Inc.
K171946	Gel-Bead	Oct 25, 2017	Substantially Equivalent	Vascular Solutions, Inc.
K172372	QuadraSphere Microspheres	Sep 06, 2017	Substantially Equivalent	Biosphere Medical, S.A.
K171845	EMBA Hourglass Peripheral Embolization Device	Aug 18, 2017	Substantially Equivalent	Emba Medical Limited
K162524	AZUR CX Detachable 18 Peripheral Coil System	Mar 03, 2017	Substantially Equivalent	MicroVention, Inc.
K162373	LC Bead LUMI	Dec 16, 2016	Substantially Equivalent	Biocompatibles UK Limited
K160219	Hilal Embolization MicroCoils	Aug 03, 2016	Substantially Equivalent	Cook Incorporated
K153778	Nester Embolization Coils, Tornado Embolization Coils	May 19, 2016	Substantially Equivalent	Cook Incorporated
K150876	Bead Block	Mar 07, 2016	Substantially Equivalent	Biocompatibles UK , Ltd.
K150870	HydroPearl Microspheres, HydroPearl Microspheres	Dec 21, 2015	Substantially Equivalent	MicroVention, Inc.
K150964	MReye Flipper Detachable Embolization Coil and Delivery System	Dec 18, 2015	Substantially Equivalent	Cook Incorporated
K150931	MReye Embolization Coils	Dec 18, 2015	Substantially Equivalent	Cook Incorporated
K152157	LC Bead LUMI	Dec 11, 2015	Substantially Equivalent	Biocompatibles UK , Ltd.
K153102	QuadraSphere Microspheres	Nov 23, 2015	Substantially Equivalent	Biosphere Medical, S.A.
K151358	AZUR CX Detachable 35 Coils	Sep 25, 2015	Substantially Equivalent	MicroVention, Inc.
K150402	Endoluminal Occlusion System-EOS	Sep 25, 2015	Substantially Equivalent	Artventive Medical Group, Inc.
K150958	LifePearl Microshperes	Sep 17, 2015	Substantially Equivalent	MicroVention, Inc.
K151187	QuadraSphere Microspheres	Jul 27, 2015	Substantially Equivalent	Biosphere Medical, S.A.
K151676	Retracta Detachable Embolization Coil	Jul 22, 2015	Substantially Equivalent	Cook Incorporated
K150108	Reverse Medical Micro Vascular Plug System	Apr 22, 2015	Substantially Equivalent	Reverse Medical Corporation
K133924	ENDOLUMINAL OCCLUSION SYSTEM (EOS)	Dec 03, 2014	Substantially Equivalent	Artventive Medical Group, Inc.
K140796	MEDUSA VASCULAR PLUG,	Dec 02, 2014	Substantially Equivalent	Endoshape, Inc.
K143038	Gel-Block 10X embolization pledgets	Nov 20, 2014	Substantially Equivalent	Vascular Solutions, Inc.
K141378	IDC INTERLOCKING DETACHABLE COIL	Oct 08, 2014	Substantially Equivalent	Boston Scientific Corporation
K141209	EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES	Aug 07, 2014	Substantially Equivalent	Celonova Biosciences, Inc.
K141313	REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM	Jun 18, 2014	Substantially Equivalent	Reverse Medical Corporation
K133237	GEL-BEAD EMBOLIZATION SPHERES	Apr 25, 2014	Substantially Equivalent	Vascular Solutions, Inc.
K133626	AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35	Dec 20, 2013	Substantially Equivalent	MicroVention, Inc.
K133282	REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM	Nov 27, 2013	Substantially Equivalent	Reverse Medical Corporation
K133208	INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM	Nov 14, 2013	Substantially Equivalent	Boston Scientific Corp
K132083	AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35	Oct 28, 2013	Substantially Equivalent	MicroVention, Inc.
K123696	MEDUSA VASCULAR PLUG	Oct 25, 2013	Substantially Equivalent	Endoshape, Inc.
K132675	EMBOZENE MICROSPHERES	Oct 03, 2013	Substantially Equivalent	Celonova Biosciences, Inc.
K132578	INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM	Sep 13, 2013	Substantially Equivalent	Boston Scientific Corp
K123803	REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM	Jul 02, 2013	Substantially Equivalent	Reverse Medical Corporation
K130577	AZUR PUSHABLE 18 & 35 SYSTEM	Jun 17, 2013	Substantially Equivalent	MicroVention, Inc.
K130307	ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE	Mar 04, 2013	Substantially Equivalent	Celonova Biosciences, Inc.
K123712	RETRACTA DETACHABLE EMBOLIZATION COIL	Jan 03, 2013	Substantially Equivalent	Cook Incorporated
K123384	AZUR CX DETACHABLE 18	Nov 28, 2012	Substantially Equivalent	MicroVention, Inc.
K122543	AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35	Nov 28, 2012	Substantially Equivalent	MicroVention, Inc.
K122316	AZUR DETACHABLE 35	Aug 29, 2012	Substantially Equivalent	MicroVention, Inc.
K113658	AMPLATZER VASCULAR PLUG 4	Jun 12, 2012	Substantially Equivalent	Aga Medical Corp.
K113266	GEL-BLOCK EMBOLIZATION PLEDGETS	May 14, 2012	Substantially Equivalent	Vascular Solutions, Inc.
K120816	INZONE DETACHMENT SYSTEM	Apr 17, 2012	Substantially Equivalent	Stryker
K120630	AZUR DETACHABLE 18	Mar 28, 2012	Substantially Equivalent	MicroVention, Inc.
K113651	INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM	Jan 11, 2012	Substantially Equivalent	Boston Scientific Corporation
K112103	INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM	Aug 12, 2011	Substantially Equivalent	Boston Scientific Corp
K111307	AZUR DETACHABLE 35 PLATINUM COIL SYSTEM	Jun 15, 2011	Substantially Equivalent	MicroVention, Inc.
K110295	INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM	Mar 03, 2011	Substantially Equivalent	Boston Scientific Corp
K102912	INTERLOCK FIBERED IDC OCCLUSION SYSTEM	Mar 03, 2011	Substantially Equivalent	Boston Scientific
K102714	COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL	Feb 11, 2011	Substantially Equivalent	Boston Scientific Corp
K102365	MICROPLEX COIL SYSTEM- COSMOS	Nov 18, 2010	Substantially Equivalent	MicroVention, Inc.
K091952	ACTA VESSEL OCCLUSION SYSTEM (VOS)	Sep 10, 2010	Substantially Equivalent	Nfocus Neuromedical, Inc.
K093813	OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE	May 10, 2010	Substantially Equivalent	Imbiotechnologies
K093002	AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610	Oct 28, 2009	Substantially Equivalent	MicroVention, Inc.
K091882	AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM	Jul 08, 2009	Substantially Equivalent	MicroVention, Inc.
K090624	COOK MREYE EMBOLIZATION COILS	Apr 02, 2009	Substantially Equivalent	Cook, Inc.
K090046	CONCERTO DETACHABLE COIL SYSTEM	Feb 27, 2009	Substantially Equivalent	Micro Therapeutics, Inc.
K083091	LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES	Dec 24, 2008	Substantially Equivalent	Biocompatibles UK Limited
K073417	EMBOZENE MICROSPHERES	Dec 15, 2008	Substantially Equivalent	Celonova Biosciences, Inc.
K081465	AXIUM DETACHABLE COIL SYSTEM	Aug 19, 2008	Substantially Equivalent	Micro Therapeutics, Inc.
K073544	PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES	Mar 05, 2008	Substantially Equivalent	Rj Medical, Inc.
K071939	HYDROCOIL EMBOLIC SYSTEMS (HES)	Jan 11, 2008	Substantially Equivalent	MicroVention, Inc.
K071699	AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022	Aug 15, 2007	Substantially Equivalent	Aga Medical Corp.
K071125	AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016	Jun 18, 2007	Substantially Equivalent	Aga Medical Corp.
K063619	FLIPPER DETACHABLE EMBOLIZATION COILS	Dec 20, 2006	Substantially Equivalent	Cook, Inc.
K052742	HEPASPHERE MICROSPHERES	Nov 07, 2006	Substantially Equivalent	Biosphere Medical, Inc.
K061790	PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES	Sep 19, 2006	Substantially Equivalent	Protein Polymer Technologies, Inc.
K060078	FIBERED IDC OCCLUSION SYSTEM	Jan 31, 2006	Substantially Equivalent	Boston Scientific Corporation
K052834	MREYE EMBOLIZATION COIL	Nov 23, 2005	Substantially Equivalent	Cook, Inc.
K050470	CONCENTRIC EMBOLIC PEARLS	May 06, 2005	Substantially Equivalent	Concentric Medical, Inc.
K043371	BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER	Feb 03, 2005	Substantially Equivalent	Biomerix Corporation
K040342	INTERLOCKING DETACHABLE COIL SYSTEM (IDC)	Apr 13, 2004	Substantially Equivalent	Boston Scientific Corp
K034068	CONTOUR SE MICROSPHERES	Mar 26, 2004	Substantially Equivalent	Boston Scientific Corp
K031810	AMPLATZER VASCULAR PLUG	Sep 09, 2003	Substantially Equivalent	Aga Medical Corp.
K993455	FLIPPER DETACHABLE EMBOLIZATION COIL	Jan 11, 2000	Substantially Equivalent	Cook, Inc.
K992121	EMBOLIZATION COIL SYSTEM	Dec 20, 1999	Substantially Equivalent	Cook, Inc.
K964112	BERENSTEIN COIL	Feb 26, 1997	Substantially Equivalent	Target Therapeutics
K955293	FIBERED PLATINUM COIL, .035 TYPE	Feb 06, 1996	Substantially Equivalent	Target Therapeutics
K940189	COIL POSITIONER SET	Nov 28, 1994	Substantially Equivalent	Cook, Inc.
K940982	ARTERIAL EMBOLIZATION DEVICE (KRD)	Oct 14, 1994	Substantially Equivalent	Cook, Inc.
K914786	TARGET THERAPEUTICS COILS	Apr 20, 1992	Substantially Equivalent	Target Therapeutics
K892446	SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02	Jul 14, 1989	Substantially Equivalent	Shiley, Inc.
K882136	INTERSEPT* OXYGEN GAS LINE FILTER	Aug 11, 1988	Substantially Equivalent	Medtronic Blood Systems, Inc.
K854273	SILICONE OIL 350 CNETISTOKE	Nov 22, 1985	Substantially Equivalent	Pacific Medical Industries