Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Device, Neurovascular Embolization

FDA product code HCG · 177 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5950
Review panel: NE
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1987-05-22 – 2026-08-14

HCG 2005-12-15

TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION

Applicant Cordis Neurovascular, Inc.

K number K053197

View details →

HCG 2005-12-07

MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE

Applicant Micrus Endovascular Corporation

K number K053160

View details →

HCG 2005-06-28

NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR

Applicant Micro Therapeutics, Inc.

K number K051560

View details →

HCG 2005-06-28

MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)

Applicant MicroVention, Inc.

K number K050954

View details →

HCG 2005-06-22

NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR

Applicant Micro Therapeutics, Inc.

K number K051425

View details →

HCG 2005-06-01

ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES

Applicant Acta Vascular Systems, Inc.

K number K042297

View details →

HCG 2005-04-27

NEXUS DETACHABLE COIL SYSTEM

Applicant Micro Therapeutics, Inc.

K number K050543

View details →

HCG 2005-04-15

MATRIX STRETCH RESISTANT (SR) COILS

Applicant Boston Scientific Corp

K number K050700

View details →

HCG 2004-11-12

GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES

Applicant Biocompatibles UK Limited

K number K042231

View details →

HCG 2004-10-19

GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL

Applicant Boston Scientific Corp

K number K042539

View details →

HCG 2004-07-16

SAPPHIRE NXT DETACHABLE COIL SYSTEM

Applicant Micro Therapeutics, Inc.

K number K041649

View details →

HCG 2004-07-07

MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)

Applicant MicroVention, Inc.

K number K041551

View details →

HCG 2004-03-25

MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)

Applicant Micro Therapeutics, Inc.

K number K040694

View details →

HCG 2004-02-13

MICROSTAT PVA FOAM EMBOLIZATION PARTICLES

Applicant Surgica Corp.

K number K032619

View details →

HCG 2004-02-04

MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE

Applicant Micrus Corp.

K number K033813

View details →

HCG 2004-02-04

GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES

Applicant Biocompatibles UK Limited

K number K033761

View details →

HCG 2004-01-09

SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS

Applicant Micro Therapeutics, Inc.

K number K033372

View details →

HCG 2003-12-30

HYDROCOIL EMBOLIC SYSTEM (HES)

Applicant MicroVention, Inc.

K number K033836

View details →

HCG 2003-11-28

MICRUS MICROCOIL SYSTEM

Applicant Micrus Corp.

K number K032872

View details →

HCG 2003-10-22

MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)

Applicant MicroVention, Inc.

K number K032590

View details →

HCG 2003-09-25

SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT

Applicant Micro Therapeutics, Inc.

K number K032497

View details →

HCG 2003-09-23

CONTOUR SE MICROSPHERES (SYRINGE)

Applicant Boston Scientific Corp

K number K032707

View details →

HCG 2003-09-23

TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

Applicant Cordis Neurovascular, Inc.

K number K032553

View details →

HCG 2003-09-16

MODIFICATION TO CONTOUR SE MICROSPHERES

Applicant Boston Scientific Corp

K number K032542

View details →

HCG 2003-08-20

SAPPHIRE DETACHABLE FIBER COILS

Applicant Micro Therapeutics, Inc.

K number K031852

View details →

HCG 2003-08-01

MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR

Applicant Micrus Corp.

K number K031578

View details →

HCG 2003-08-01

GUGLIELMI DETACHABLE COIL (GDC)

Applicant Boston Scientific, Target

K number K031049

View details →

HCG 2003-07-21

SAPPHIRE DETACHABLE COIL SYSTEM

Applicant Micro Therapeutics, Inc.

K number K030392

View details →

HCG 2003-06-20

TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

Applicant Cordis Neurovascular, Inc.

K number K030963

View details →

HCG 2003-05-14

MATRIX STRETCH RESISTANT DETACHABLE COIL

Applicant Boston Scientific, Target

K number K031168

View details →

HCG 2003-03-14

GDC STRETCH RESISTANT DETACHABLE COIL

Applicant Boston Scientific, Target

K number K030475

View details →

HCG 2002-12-16

GELSPHERES EMBOLIC AGENT

Applicant Biocure, Inc.

K number K023089

View details →

HCG 2002-10-22

MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01

Applicant Micrus Corp.

K number K022420

View details →

HCG 2002-09-06

MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT

Applicant MicroVention, Inc.

K number K022735

View details →

HCG 2002-08-22

CONTOUR SE MICROSPHERES

Applicant Boston Scientific Corp

K number K022427

View details →

HCG 2002-07-29

MICROPLEX COIL SYSTEM (MCS)

Applicant MicroVention, Inc.

K number K020434

View details →

HCG 2002-07-09

MICROPLEX COIL SYSTEMS (MCS)

Applicant MicroVention, Inc.

K number K021914

View details →

HCG 2002-06-06

GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4

Applicant Boston Scientific, Target

K number K021494

View details →

HCG 2002-05-31

MAXISTAT PVA FOAM EMBOLIZATION PARTICLES

Applicant Surgica Corp.

K number K020033

View details →

HCG 2002-03-07

TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM

Applicant Cordis Neurovascular

K number K014041

View details →

HCG 2002-01-31

MATRIX DETACHABLE COILS

Applicant Boston Scientific, Target

K number K012985

View details →

HCG 2001-10-29

MICROPLEX COIL SYSTEM

Applicant MicroVention, Inc.

K number K012145

View details →

HCG 2001-06-21

EMBOGOLD MICROSPHERE

Applicant Biosphere Medical, Inc.

K number K010026

View details →

HCG 2001-01-25

PVA FOAM EMBOLIZATION PARTICLES

Applicant Surgica Corp.

K number K001678

View details →

HCG 2001-01-11

MICRUS MICROCOIL DELIVERY SYSTEM, MDS03

Applicant Micrus Corp.

K number K002056

View details →

HCG 2000-11-24

DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM

Applicant Cook, Inc.

K number K000651

View details →

HCG 2000-08-11

GDC ULTRASOFT COIL

Applicant Boston Scientific, Target

K number K002181

View details →

HCG 2000-05-03

GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4

Applicant Boston Scientific, Target

K number K001083

View details →

HCG 2000-04-26

EMBOSPHERE MICROSPHERES

Applicant Biosphere Medical

K number K991549

View details →

HCG 2000-01-21

FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL

Applicant Boston Scientific, Target

K number K993418

View details →

HCG 2000-01-21

GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)

Applicant Boston Scientific, Target

K number K993417

View details →

HCG 2000-01-21

GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1

Applicant Boston Scientific, Target

K number K993415

View details →

HCG 1999-12-22

GUGLIELMI DETACHABLE (GDC)

Applicant Boston Scientific, Target

K number K991139

View details →

HCG 1999-03-24

VASCULAR OCCLUSION SYSTEM

Applicant Cordis Neurovascular, Inc.

K number K983483

View details →

HCG 1998-06-04

CES VASCULAR OCCLUSION SYSTEM

Applicant Cordis Neurovascular, Inc.

K number K972881

View details →

HCG 1997-03-27

INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)

Applicant Baxter Edwards

K number K964021

View details →

HCG 1997-03-21

TRUFILL PVA PARTICLES

Applicant Cordis Neurovascular, Inc.

K number K965174

View details →

HCG 1997-01-30

CES VASCULAR OCCLUSION SYSTEM

Applicant Cordis Neurovascular, Inc.

K number K964367

View details →

HCG 1996-12-17

GDC PATIENT RETURN ELECTTRODE MODEL 45021

Applicant Target Therapeutics

K number K963307

View details →

HCG 1996-09-20

GUGLIELMI DETACHABLE COIL

Applicant Target Therapeutics

K number K962503

View details →

HCG 1996-08-15

BERENSTEIN COIL

Applicant Target Therapeutics

K number K961923

View details →

HCG 1996-05-21

GUGLIELMI DETACHABLE COIL

Applicant Target Therapeutics

K number K960705

View details →

HCG 1995-09-08

DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)

Applicant Target Therapeutics

K number K951256

View details →

HCG 1995-08-08

TRUEFILL PVA PARTICLES

Applicant Cordis Neurovascular, Inc.

K number K951314

View details →

HCG 1994-12-13

CONTOUR EMBOLI

Applicant Interventional Therapeutics Corp.

K number K944354

View details →

HCG 1994-04-13

IVALON EMBOLIZATION PARTICLES

Applicant Ivalon

K number K913556

View details →

HCG 1993-11-09

ITC CONTOUR EMBOLI, MODIFICATION

Applicant Interventional Therapeutics Corp.

K number K914866

View details →

HCG 1993-04-15

ITC BUNJI PLATINUM EMBOLIZATION COIL

Applicant Interventional Therapeutics Corp.

K number K925876

View details →

HCG 1993-03-23

ITC BUNJI PLATINUM EMBOLIZATION COIL

Applicant Interventional Therapeutics Corp.

K number K925523

View details →

HCG 1992-07-29

ITC BUNJI COIL (MODIFICATION)

Applicant Interventional Therapeutics Corp.

K number K920324

View details →

HCG 1991-11-08

HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED

Applicant Target Therapeutics

K number K913312

View details →

HCG 1991-11-08

HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED

Applicant Target Therapeutics

K number K911779

View details →

HCG 1991-02-19

ITC BUNJI COIL

Applicant Interventional Therapeutics Corp.

K number K900723

View details →

HCG 1990-11-13

HILAL EMBOLIZATION MICROCOIL(TM)

Applicant Cook, Inc.

K number K901337

View details →

HCG 1990-07-03

MODIFIED TARGET THERAPEUTICS COILS

Applicant Target Therapeutics

K number K901721

View details →

HCG 1989-09-22

COIL AND COIL DELIVERY SYSTEM

Applicant Target Therapeutics

K number K891688

View details →

HCG 1987-05-22

RADIOPAQUE SPHERICAL EMBOLI (RSE)

Applicant Interventional Therapeutics Corp.

K number K871047

View details →

↑