Device, Vascular, For Promoting Embolization

FDA product code KRD · 114 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.3300
Review panel: CV
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1985-11-22 – 2026-07-31

KRD 2026-07-31

UniPearls® Embolic Microspheres

Applicant Suzhou Haowei Medical Technology Co., Ltd.

K number K252812

View details →

KRD 2026-07-24

OBSIDIO Conformable Embolic

Applicant Boston Scientific Corporation

K number K261488

View details →

KRD 2026-06-24

Concerto Versa™ Detachable Coil

Applicant Medtronic, Inc.

K number K261866

View details →

KRD 2026-06-12

HARBOR Occlusion Device

Applicant Nuvascular, Inc.

K number K260635

View details →

KRD 2026-04-10

LOBO Vascular Occlusion System

Applicant Okami Medical, Inc.

K number K260508

View details →

KRD 2026-01-14

Concerto Versa™ Detachable Coil

Applicant Medtronic, Inc.

K number K253511

View details →

KRD 2025-12-15

Tembo Embolic System

Applicant Instylla, Inc.

K number K253677

View details →

KRD 2025-10-30

OBSIDIO™ Conformable Embolic (M0013972101010)

Applicant Boston Scientific Corporation

K number K253376

View details →

KRD 2025-09-23

Polyvinyl Alcohol Embolic Microspheres

Applicant Canyon Medical, Inc.

K number K250209

View details →

KRD 2025-07-09

HARBOR Occlusion Device

Applicant Nuvascular, Inc.

K number K250133

View details →

KRD 2025-05-30

Prestige Coil System (Prestige Packing Line Extension)

Applicant Balt USA, LLC

K number K251383

View details →

KRD 2025-05-16

Embosphere Microspheres

Applicant Biosphere Medical, S.A.

K number K250971

View details →

KRD 2025-05-15

Nitinol Enhanced Device (NED)

Applicant Embolization, Inc.

K number K250276

View details →

KRD 2025-03-14

Ruby XL System

Applicant Penumbra, Inc.

K number K250079

View details →

KRD 2025-01-17

Embozene Color-Advanced Microspheres

Applicant Varian Medical Systems, Inc.

K number K242608

View details →

KRD 2024-12-16

TEMBO Embolic System

Applicant Instylla, Inc.

K number K240873

View details →

KRD 2024-10-16

ONCOZENE Microspheres

Applicant Varian Medical Systems, Inc.

K number K242794

View details →

KRD 2024-10-03

OBSIDIO™ Conformable Embolic

Applicant Boston Scientific

K number K242507

View details →

KRD 2024-05-30

Sunsphere

Applicant Hangzhou Yangshun Medical Technology Co.,Ltd

K number K232934

View details →

KRD 2024-05-02

Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)

Applicant Merit Medical Systems, Inc.

K number K240261

View details →

KRD 2024-02-13

Easi-Vue® embolic microspheres System

Applicant Abk Biomedical, Inc.

K number K234123

View details →

KRD 2023-11-14

UniPearls® Embolic Microspheres

Applicant Suzhou Haowei Medical Technology Co., Ltd.

K number K231554

View details →

KRD 2023-06-27

EMBOLD™ Soft Detachable Coil System

Applicant Boston Scientific Corporation

K number K230706

View details →

KRD 2022-12-21

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)

Applicant MicroVention, Inc.

K number K223050

View details →

KRD 2022-09-07

Easi-Vue embolic microspheres System

Applicant Abk Biomedical, Inc.

K number K220567

View details →

KRD 2022-07-01

GEM

Applicant Obsidio, Inc.

K number K213385

View details →

KRD 2022-04-29

LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)

Applicant Okami Medical

K number K220383

View details →

KRD 2022-04-12

EMBOLD Fibered Detachable Coil System

Applicant Boston Scientific Corporation

K number K213398

View details →

KRD 2022-04-08

Prestige Coil System

Applicant Bait USA, LLC

K number K220699

View details →

KRD 2022-03-21

Solus Gold Embolization Device

Applicant Artio Medical, Inc.

K number K213200

View details →

KRD 2022-03-01

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS

Applicant Artventive Medical Group, Inc.

K number K212057

View details →

KRD 2021-12-15

Merit Siege Vascular Plug

Applicant Merit Medical System, Inc.

K number K212817

View details →

KRD 2021-10-01

HRSpheres Narrow-Size Embolic Microspheres

Applicant Suzhou Hengrui Hongyuan Medical Co., Ltd.

K number K210562

View details →

KRD 2021-02-09

Concerto Versa, Detachable Coil

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K number K202850

View details →

KRD 2020-11-05

LOBO Vascular Occlusion System (model LOBO-5)

Applicant Okami Medical

K number K203025

View details →

KRD 2020-03-20

AZUR Vascular Plug

Applicant MicroVention, Inc.

K number K191680

View details →

KRD 2020-02-14

EMBA Hourglass Peripheral Embolization Device (PED)

Applicant Embolic Acceleration, LLC

K number K200083

View details →

KRD 2020-02-04

The Caterpillar and Caterpillar Micro Arterial Embolization Devices

Applicant C.R. Bard, Inc.

K number K191532

View details →

KRD 2019-11-21

Torpedo Gelatin Foam

Applicant Biosphere Medical, S.A.

K number K192480

View details →

KRD 2019-10-30

Okami Medical LOBO Vascular Occlusion System

Applicant Okami Medical

K number K192083

View details →

KRD 2019-08-06

EmboCube Embolization Gelatin

Applicant Biosphere Medical, S.A.

K number K183120

View details →

KRD 2019-06-18

Torpedo Gelatin Foam

Applicant Biosphere Medical, S.A.

K number K183578

View details →

KRD 2019-05-23

IMPEDE-FX Embolization Plug

Applicant Shape Memory Medical

K number K182390

View details →

KRD 2019-04-17

Dr. Amplatz Micro Plug

Applicant Ka Medical, LLC

K number K182944

View details →

KRD 2018-09-27

EmboCube Embolization Gelatin

Applicant Biosphere Medical, S.A.

K number K181021

View details →

KRD 2018-07-16

Embosphere Microspheres

Applicant Biosphere Medical, S.A.

K number K181300

View details →

KRD 2018-06-22

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm

Applicant Shape Memory Medical

K number K181051

View details →

KRD 2018-01-19

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume

Applicant Vascular Solutions, Inc.

K number K173891

View details →

KRD 2017-10-25

Gel-Bead

Applicant Vascular Solutions, Inc.

K number K171946

View details →

KRD 2017-09-06

QuadraSphere Microspheres

Applicant Biosphere Medical, S.A.

K number K172372

View details →

KRD 2017-08-18

EMBA Hourglass Peripheral Embolization Device

Applicant Emba Medical Limited

K number K171845

View details →

KRD 2017-03-03

AZUR CX Detachable 18 Peripheral Coil System

Applicant MicroVention, Inc.

K number K162524

View details →

KRD 2016-12-16

LC Bead LUMI

Applicant Biocompatibles UK Limited

K number K162373

View details →

KRD 2016-08-03

Hilal Embolization MicroCoils

Applicant Cook Incorporated

K number K160219

View details →

KRD 2016-05-19

Nester Embolization Coils, Tornado Embolization Coils

Applicant Cook Incorporated

K number K153778

View details →

KRD 2016-03-07

Bead Block

Applicant Biocompatibles UK , Ltd.

K number K150876

View details →

KRD 2013-12-20

AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35

Applicant MicroVention, Inc.

K number K133626

View details →

KRD 2013-11-27

REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM

Applicant Reverse Medical Corporation

K number K133282

View details →

KRD 2013-11-14

INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM

Applicant Boston Scientific Corp

K number K133208

View details →

KRD 2013-10-28

AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35

Applicant MicroVention, Inc.

K number K132083

View details →

KRD 2013-10-25

MEDUSA VASCULAR PLUG

Applicant Endoshape, Inc.

K number K123696

View details →

KRD 2013-10-03

EMBOZENE MICROSPHERES

Applicant Celonova Biosciences, Inc.

K number K132675

View details →

KRD 2013-09-13

INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM

Applicant Boston Scientific Corp

K number K132578

View details →

KRD 2013-07-02

REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM

Applicant Reverse Medical Corporation

K number K123803

View details →

KRD 2013-06-17

AZUR PUSHABLE 18 & 35 SYSTEM

Applicant MicroVention, Inc.

K number K130577

View details →

KRD 2013-03-04

ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE

Applicant Celonova Biosciences, Inc.

K number K130307

View details →

KRD 2013-01-03

RETRACTA DETACHABLE EMBOLIZATION COIL

Applicant Cook Incorporated

K number K123712

View details →

KRD 2012-11-28

AZUR CX DETACHABLE 18

Applicant MicroVention, Inc.

K number K123384

View details →

KRD 2012-11-28

AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35

Applicant MicroVention, Inc.

K number K122543

View details →

KRD 2012-08-29

AZUR DETACHABLE 35

Applicant MicroVention, Inc.

K number K122316

View details →

KRD 2012-06-12

AMPLATZER VASCULAR PLUG 4

Applicant Aga Medical Corp.

K number K113658

View details →

KRD 2012-05-14

GEL-BLOCK EMBOLIZATION PLEDGETS

Applicant Vascular Solutions, Inc.

K number K113266

View details →

KRD 2012-04-17

INZONE DETACHMENT SYSTEM

Applicant Stryker

K number K120816

View details →

KRD 2012-03-28

AZUR DETACHABLE 18

Applicant MicroVention, Inc.

K number K120630

View details →

KRD 2012-01-11

INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM

Applicant Boston Scientific Corporation

K number K113651

View details →

KRD 2011-08-12

INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM

Applicant Boston Scientific Corp

K number K112103

View details →

KRD 2011-06-15

AZUR DETACHABLE 35 PLATINUM COIL SYSTEM

Applicant MicroVention, Inc.

K number K111307

View details →

KRD 2011-03-03

INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM

Applicant Boston Scientific Corp

K number K110295

View details →

KRD 2011-03-03

INTERLOCK FIBERED IDC OCCLUSION SYSTEM

Applicant Boston Scientific

K number K102912

View details →

KRD 2011-02-11

COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL

Applicant Boston Scientific Corp

K number K102714

View details →

KRD 2010-11-18

MICROPLEX COIL SYSTEM- COSMOS

Applicant MicroVention, Inc.

K number K102365

View details →

KRD 2010-09-10

ACTA VESSEL OCCLUSION SYSTEM (VOS)

Applicant Nfocus Neuromedical, Inc.

K number K091952

View details →

KRD 2010-05-10

OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE

Applicant Imbiotechnologies

K number K093813

View details →

KRD 2009-10-28

AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610

Applicant MicroVention, Inc.

K number K093002

View details →

KRD 2009-07-08

AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM

Applicant MicroVention, Inc.

K number K091882

View details →

KRD 2009-04-02

COOK MREYE EMBOLIZATION COILS

Applicant Cook, Inc.

K number K090624

View details →

KRD 2009-02-27

CONCERTO DETACHABLE COIL SYSTEM

Applicant Micro Therapeutics, Inc.

K number K090046

View details →

KRD 2008-12-24

LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES

Applicant Biocompatibles UK Limited

K number K083091

View details →

KRD 2008-12-15

EMBOZENE MICROSPHERES

Applicant Celonova Biosciences, Inc.

K number K073417

View details →

KRD 2008-08-19

AXIUM DETACHABLE COIL SYSTEM

Applicant Micro Therapeutics, Inc.

K number K081465

View details →

KRD 2008-03-05

PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES

Applicant Rj Medical, Inc.

K number K073544

View details →

KRD 2008-01-11

HYDROCOIL EMBOLIC SYSTEMS (HES)

Applicant MicroVention, Inc.

K number K071939

View details →

KRD 2007-08-15

AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022

Applicant Aga Medical Corp.

K number K071699

View details →

KRD 2007-06-18

AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016

Applicant Aga Medical Corp.

K number K071125

View details →

KRD 2006-12-20

FLIPPER DETACHABLE EMBOLIZATION COILS

Applicant Cook, Inc.

K number K063619

View details →

KRD 2006-11-07

HEPASPHERE MICROSPHERES

Applicant Biosphere Medical, Inc.

K number K052742

View details →

KRD 2006-09-19

PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES

Applicant Protein Polymer Technologies, Inc.

K number K061790

View details →

KRD 2006-01-31

FIBERED IDC OCCLUSION SYSTEM

Applicant Boston Scientific Corporation

K number K060078

View details →

KRD 2005-11-23

MREYE EMBOLIZATION COIL

Applicant Cook, Inc.

K number K052834

View details →

KRD 2005-05-06

CONCENTRIC EMBOLIC PEARLS

Applicant Concentric Medical, Inc.

K number K050470

View details →