Product code HCG— Neurology
HYDROCOIL EMBOLIC SYSTEM (HES)
- Classification name
- Device, Neurovascular Embolization
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Total cleared
- 187
- First cleared
- Most recent
Clearances under product code HCG — page 2
101–187 of 187- K070656 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K071246 — MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
- K060747 — FX DETACHABLE COIL SYSTEM
- K070707 — MICRUS MICROCOIL SYSTEM
- K063653 — MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
- K052509 — M-BOLUS EMBOLIC MICROSPHERES
- K063254 — THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K062036 — MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
- K060625 — NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
- K053548 — MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
- K053197 — TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
- K053160 — MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
- K050954 — MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
- K051560 — NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
- K051425 — NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
- K042297 — ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
- K050543 — NEXUS DETACHABLE COIL SYSTEM
- K050700 — MATRIX STRETCH RESISTANT (SR) COILS
- K042231 — GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
- K042539 — GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL
- K041649 — SAPPHIRE NXT DETACHABLE COIL SYSTEM
- K041551 — MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
- K040694 — MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
- K032619 — MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
- K033761 — GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
- K033813 — MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
- K033372 — SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
- K033836 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K032872 — MICRUS MICROCOIL SYSTEM
- K032590 — MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
- K032497 — SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
- K032553 — TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K032707 — CONTOUR SE MICROSPHERES (SYRINGE)
- K032542 — MODIFICATION TO CONTOUR SE MICROSPHERES
- K031852 — SAPPHIRE DETACHABLE FIBER COILS
- K031049 — GUGLIELMI DETACHABLE COIL (GDC)
- K031578 — MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
- K030392 — SAPPHIRE DETACHABLE COIL SYSTEM
- K030963 — TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K031168 — MATRIX STRETCH RESISTANT DETACHABLE COIL
- K030475 — GDC STRETCH RESISTANT DETACHABLE COIL
- K023089 — GELSPHERES EMBOLIC AGENT
- K022420 — MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
- K022735 — MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
- K022427 — CONTOUR SE MICROSPHERES
- K020434 — MICROPLEX COIL SYSTEM (MCS)
- K021914 — MICROPLEX COIL SYSTEMS (MCS)
- K021494 — GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
- K020033 — MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
- K014041 — TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM
- K012985 — MATRIX DETACHABLE COILS
- K012145 — MICROPLEX COIL SYSTEM
- K010026 — EMBOGOLD MICROSPHERE
- K001678 — PVA FOAM EMBOLIZATION PARTICLES
- K002056 — MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
- K000651 — DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
- K002181 — GDC ULTRASOFT COIL
- K001083 — GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4
- K991549 — EMBOSPHERE MICROSPHERES
- K993415 — GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
- K993417 — GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
- K993418 — FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
- K991139 — GUGLIELMI DETACHABLE (GDC)
- K983483 — VASCULAR OCCLUSION SYSTEM
- K972881 — CES VASCULAR OCCLUSION SYSTEM
- K964021 — INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
- K965174 — TRUFILL PVA PARTICLES
- K964367 — CES VASCULAR OCCLUSION SYSTEM
- K963307 — GDC PATIENT RETURN ELECTTRODE MODEL 45021
- K962503 — GUGLIELMI DETACHABLE COIL
- K961923 — BERENSTEIN COIL
- K960705 — GUGLIELMI DETACHABLE COIL
- K951256 — DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
- K951314 — TRUEFILL PVA PARTICLES
- K944354 — CONTOUR EMBOLI
- K913556 — IVALON EMBOLIZATION PARTICLES
- K914866 — ITC CONTOUR EMBOLI, MODIFICATION
- K925876 — ITC BUNJI PLATINUM EMBOLIZATION COIL
- K925523 — ITC BUNJI PLATINUM EMBOLIZATION COIL
- K920324 — ITC BUNJI COIL (MODIFICATION)
- K911779 — HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
- K913312 — HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
- K900723 — ITC BUNJI COIL
- K901337 — HILAL EMBOLIZATION MICROCOIL(TM)
- K901721 — MODIFIED TARGET THERAPEUTICS COILS
- K891688 — COIL AND COIL DELIVERY SYSTEM
- K871047 — RADIOPAQUE SPHERICAL EMBOLI (RSE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.