ClearanceBrief
Panels › Neurology › Product code HCG · Class 2

Device, Neurovascular Embolization

Regulation 882.5950

5510(k)s in 12 months (187 all time)
2recalls in 12 months (68 all time)
67recalls that name a 510(k)
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Top companies in HCG

Decided510(k)Device and applicantCode
Jan 31, 2002K012985MATRIX DETACHABLE COILS
Boston Scientific, Target
HCG
Oct 29, 2001K012145MICROPLEX COIL SYSTEM
MicroVention, Inc.
HCG
Jun 21, 2001K010026EMBOGOLD MICROSPHERE
Biosphere Medical, Inc.
HCG
Jan 25, 2001K001678PVA FOAM EMBOLIZATION PARTICLES
Surgica Corp.
HCG
Jan 11, 2001K002056MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
Micrus Corp.
HCG
Nov 24, 2000K000651DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
Cook, Inc.
HCG
Aug 11, 2000K002181GDC ULTRASOFT COIL
Boston Scientific, Target
HCG
May 3, 2000K001083GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4
Boston Scientific, Target
HCG
Apr 26, 2000K991549EMBOSPHERE MICROSPHERES
Biosphere Medical
HCG
Jan 21, 2000K993418FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
Boston Scientific, Target
HCG
Jan 21, 2000K993417GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
Boston Scientific, Target
HCG
Jan 21, 2000K993415GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
Boston Scientific, Target
HCG
Dec 22, 1999K991139GUGLIELMI DETACHABLE (GDC)
Boston Scientific, Target
HCG
Mar 24, 1999K983483VASCULAR OCCLUSION SYSTEM
Cordis Neurovascular, Inc.
HCG
Jun 4, 1998K972881CES VASCULAR OCCLUSION SYSTEM
Cordis Neurovascular, Inc.
HCG
Mar 27, 1997K964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
Baxter Edwards
HCG
Mar 21, 1997K965174TRUFILL PVA PARTICLES
Cordis Neurovascular, Inc.
HCG
Jan 30, 1997K964367CES VASCULAR OCCLUSION SYSTEM
Cordis Neurovascular, Inc.
HCG
Dec 17, 1996K963307GDC PATIENT RETURN ELECTTRODE MODEL 45021
Target Therapeutics
HCG
Sep 20, 1996K962503GUGLIELMI DETACHABLE COIL
Target Therapeutics
HCG
Aug 15, 1996K961923BERENSTEIN COIL
Target Therapeutics
HCG
May 21, 1996K960705GUGLIELMI DETACHABLE COIL
Target Therapeutics
HCG
Sep 8, 1995K951256DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
Target Therapeutics
HCG
Aug 8, 1995K951314TRUEFILL PVA PARTICLES
Cordis Neurovascular, Inc.
HCG
Dec 13, 1994K944354CONTOUR EMBOLI
Interventional Therapeutics Corp.
HCG
Apr 13, 1994K913556IVALON EMBOLIZATION PARTICLES
Ivalon
HCG
Nov 9, 1993K914866ITC CONTOUR EMBOLI, MODIFICATION
Interventional Therapeutics Corp.
HCG
Apr 15, 1993K925876ITC BUNJI PLATINUM EMBOLIZATION COIL
Interventional Therapeutics Corp.
HCG
Mar 23, 1993K925523ITC BUNJI PLATINUM EMBOLIZATION COIL
Interventional Therapeutics Corp.
HCG
Jul 29, 1992K920324ITC BUNJI COIL (MODIFICATION)
Interventional Therapeutics Corp.
HCG
Nov 8, 1991K913312HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
Target Therapeutics
HCG
Nov 8, 1991K911779HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
Target Therapeutics
HCG
Feb 19, 1991K900723ITC BUNJI COIL
Interventional Therapeutics Corp.
HCG
Nov 13, 1990K901337HILAL EMBOLIZATION MICROCOIL(TM)
Cook, Inc.
HCG
Jul 3, 1990K901721MODIFIED TARGET THERAPEUTICS COILS
Target Therapeutics
HCG
Sep 22, 1989K891688COIL AND COIL DELIVERY SYSTEM
Target Therapeutics
HCG
May 22, 1987K871047RADIOPAQUE SPHERICAL EMBOLI (RSE)
Interventional Therapeutics Corp.
HCG

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