FDA Product Code
FDA Product Code HCG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5950
510(k) Clearances — 187 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K070656 | HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2007-06-15 | Traditional | PDF ↗ |
| K071246 | MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR | Micrus Endovascular Corporation | 2007-06-01 | Special | PDF ↗ |
| K060747 | FX DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2007-04-24 | Traditional | PDF ↗ |
| K070707 | MICRUS MICROCOIL SYSTEM | Micrus Endovascular Corporation | 2007-04-06 | Special | PDF ↗ |
| K063653 | MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC | Micrus Endovascular Corporation | 2007-01-17 | Special | PDF ↗ |
| K052509 | M-BOLUS EMBOLIC MICROSPHERES | Scion Cardio-Vascular, Inc. | 2006-12-11 | Abbreviated | PDF ↗ |
| K063254 | THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | Cordis Neurovascular, Inc. | 2006-12-07 | Traditional | PDF ↗ |
| K062036 | MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 | Micrus Endovascular Corporation | 2006-08-25 | Traditional | PDF ↗ |
| K060625 | NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR | Micro Therapeutics, Inc. | 2006-04-20 | Special | PDF ↗ |
| K053548 | MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES | Protein Polymer Technologies, Inc. | 2006-01-30 | Traditional | PDF ↗ |
| K053197 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION | Cordis Neurovascular, Inc. | 2005-12-15 | Special | PDF ↗ |
| K053160 | MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE | Micrus Endovascular Corporation | 2005-12-07 | Special | PDF ↗ |
| K051560 | NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR | Micro Therapeutics, Inc. | 2005-06-28 | Special | PDF ↗ |
| K050954 | MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2005-06-28 | Traditional | PDF ↗ |
| K051425 | NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR | Micro Therapeutics, Inc. | 2005-06-22 | Special | PDF ↗ |
| K042297 | ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES | Acta Vascular Systems, Inc. | 2005-06-01 | Abbreviated | PDF ↗ |
| K050543 | NEXUS DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2005-04-27 | Traditional | PDF ↗ |
| K050700 | MATRIX STRETCH RESISTANT (SR) COILS | Boston Scientific Corp | 2005-04-15 | Special | PDF ↗ |
| K042231 | GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES | Biocompatibles UK Limited | 2004-11-12 | Traditional | PDF ↗ |
| K042539 | GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL | Boston Scientific Corp | 2004-10-19 | Special | PDF ↗ |
| K041649 | SAPPHIRE NXT DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2004-07-16 | Special | PDF ↗ |
| K041551 | MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2004-07-07 | Special | PDF ↗ |
| K040694 | MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) | Micro Therapeutics, Inc. | 2004-03-25 | Special | PDF ↗ |
| K032619 | MICROSTAT PVA FOAM EMBOLIZATION PARTICLES | Surgica Corp. | 2004-02-13 | Special | PDF ↗ |
| K033761 | GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES | Biocompatibles UK Limited | 2004-02-04 | Traditional | PDF ↗ |
| K033813 | MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE | Micrus Corp. | 2004-02-04 | Traditional | PDF ↗ |
| K033372 | SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS | Micro Therapeutics, Inc. | 2004-01-09 | Traditional | PDF ↗ |
| K033836 | HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2003-12-30 | Special | PDF ↗ |
| K032872 | MICRUS MICROCOIL SYSTEM | Micrus Corp. | 2003-11-28 | Traditional | PDF ↗ |
| K032590 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2003-10-22 | Traditional | PDF ↗ |
| K032497 | SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT | Micro Therapeutics, Inc. | 2003-09-25 | Special | PDF ↗ |
| K032553 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | Cordis Neurovascular, Inc. | 2003-09-23 | Special | PDF ↗ |
| K032707 | CONTOUR SE MICROSPHERES (SYRINGE) | Boston Scientific Corp | 2003-09-23 | Special | PDF ↗ |
| K032542 | MODIFICATION TO CONTOUR SE MICROSPHERES | Boston Scientific Corp | 2003-09-16 | Special | PDF ↗ |
| K031852 | SAPPHIRE DETACHABLE FIBER COILS | Micro Therapeutics, Inc. | 2003-08-20 | Traditional | PDF ↗ |
| K031578 | MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR | Micrus Corp. | 2003-08-01 | Traditional | PDF ↗ |
| K031049 | GUGLIELMI DETACHABLE COIL (GDC) | Boston Scientific, Target | 2003-08-01 | Traditional | PDF ↗ |
| K030392 | SAPPHIRE DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2003-07-21 | Traditional | PDF ↗ |
| K030963 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | Cordis Neurovascular, Inc. | 2003-06-20 | Traditional | PDF ↗ |
| K031168 | MATRIX STRETCH RESISTANT DETACHABLE COIL | Boston Scientific, Target | 2003-05-14 | Special | PDF ↗ |
| K030475 | GDC STRETCH RESISTANT DETACHABLE COIL | Boston Scientific, Target | 2003-03-14 | Special | PDF ↗ |
| K023089 | GELSPHERES EMBOLIC AGENT | Biocure, Inc. | 2002-12-16 | Traditional | PDF ↗ |
| K022420 | MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 | Micrus Corp. | 2002-10-22 | Traditional | PDF ↗ |
| K022735 | MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT | MicroVention, Inc. | 2002-09-06 | Special | PDF ↗ |
| K022427 | CONTOUR SE MICROSPHERES | Boston Scientific Corp | 2002-08-22 | Special | PDF ↗ |
| K020434 | MICROPLEX COIL SYSTEM (MCS) | MicroVention, Inc. | 2002-07-29 | Traditional | PDF ↗ |
| K021914 | MICROPLEX COIL SYSTEMS (MCS) | MicroVention, Inc. | 2002-07-09 | Special | PDF ↗ |
| K021494 | GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 | Boston Scientific, Target | 2002-06-06 | Special | PDF ↗ |
| K020033 | MAXISTAT PVA FOAM EMBOLIZATION PARTICLES | Surgica Corp. | 2002-05-31 | Special | PDF ↗ |
| K014041 | TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM | Cordis Neurovascular | 2002-03-07 | Traditional | PDF ↗ |
| K012985 | MATRIX DETACHABLE COILS | Boston Scientific, Target | 2002-01-31 | Traditional | PDF ↗ |
| K012145 | MICROPLEX COIL SYSTEM | MicroVention, Inc. | 2001-10-29 | Traditional | PDF ↗ |
| K010026 | EMBOGOLD MICROSPHERE | Biosphere Medical, Inc. | 2001-06-21 | Special | PDF ↗ |
| K001678 | PVA FOAM EMBOLIZATION PARTICLES | Surgica Corp. | 2001-01-25 | Traditional | PDF ↗ |
| K002056 | MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 | Micrus Corp. | 2001-01-11 | Traditional | PDF ↗ |
| K000651 | DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM | Cook, Inc. | 2000-11-24 | Traditional | PDF ↗ |
| K002181 | GDC ULTRASOFT COIL | Boston Scientific, Target | 2000-08-11 | Special | PDF ↗ |
| K001083 | GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 | Boston Scientific, Target | 2000-05-03 | Special | PDF ↗ |
| K991549 | EMBOSPHERE MICROSPHERES | Biosphere Medical | 2000-04-26 | Traditional | PDF ↗ |
| K993418 | FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL | Boston Scientific, Target | 2000-01-21 | Traditional | PDF ↗ |
| K993417 | GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) | Boston Scientific, Target | 2000-01-21 | Traditional | PDF ↗ |
| K993415 | GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1 | Boston Scientific, Target | 2000-01-21 | Traditional | PDF ↗ |
| K991139 | GUGLIELMI DETACHABLE (GDC) | Boston Scientific, Target | 1999-12-22 | Traditional | PDF ↗ |
| K983483 | VASCULAR OCCLUSION SYSTEM | Cordis Neurovascular, Inc. | 1999-03-24 | Traditional | PDF ↗ |
| K972881 | CES VASCULAR OCCLUSION SYSTEM | Cordis Neurovascular, Inc. | 1998-06-04 | Traditional | PDF ↗ |
| K964021 | INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) | Baxter Edwards | 1997-03-27 | Traditional | PDF ↗ |
| K965174 | TRUFILL PVA PARTICLES | Cordis Neurovascular, Inc. | 1997-03-21 | Traditional | PDF ↗ |
| K964367 | CES VASCULAR OCCLUSION SYSTEM | Cordis Neurovascular, Inc. | 1997-01-30 | Traditional | PDF ↗ |
| K963307 | GDC PATIENT RETURN ELECTTRODE MODEL 45021 | Target Therapeutics | 1996-12-17 | Traditional | PDF ↗ |
| K962503 | GUGLIELMI DETACHABLE COIL | Target Therapeutics | 1996-09-20 | Traditional | PDF ↗ |
| K961923 | BERENSTEIN COIL | Target Therapeutics | 1996-08-15 | Traditional | PDF ↗ |
| K960705 | GUGLIELMI DETACHABLE COIL | Target Therapeutics | 1996-05-21 | Traditional | PDF ↗ |
| K951256 | DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) | Target Therapeutics | 1995-09-08 | Traditional | PDF ↗ |
| K951314 | TRUEFILL PVA PARTICLES | Cordis Neurovascular, Inc. | 1995-08-08 | Traditional | PDF ↗ |
| K944354 | CONTOUR EMBOLI | Interventional Therapeutics Corp. | 1994-12-13 | Traditional | PDF ↗ |
| K913556 | IVALON EMBOLIZATION PARTICLES | Ivalon | 1994-04-13 | Traditional | PDF ↗ |
| K914866 | ITC CONTOUR EMBOLI, MODIFICATION | Interventional Therapeutics Corp. | 1993-11-09 | Traditional | PDF ↗ |
| K925876 | ITC BUNJI PLATINUM EMBOLIZATION COIL | Interventional Therapeutics Corp. | 1993-04-15 | Traditional | PDF ↗ |
| K925523 | ITC BUNJI PLATINUM EMBOLIZATION COIL | Interventional Therapeutics Corp. | 1993-03-23 | Traditional | PDF ↗ |
| K920324 | ITC BUNJI COIL (MODIFICATION) | Interventional Therapeutics Corp. | 1992-07-29 | Traditional | PDF ↗ |
| K913312 | HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED | Target Therapeutics | 1991-11-08 | Traditional | PDF ↗ |
| K911779 | HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED | Target Therapeutics | 1991-11-08 | Traditional | PDF ↗ |
| K900723 | ITC BUNJI COIL | Interventional Therapeutics Corp. | 1991-02-19 | Traditional | PDF ↗ |
| K901337 | HILAL EMBOLIZATION MICROCOIL(TM) | Cook, Inc. | 1990-11-13 | Traditional | PDF ↗ |
| K901721 | MODIFIED TARGET THERAPEUTICS COILS | Target Therapeutics | 1990-07-03 | Traditional | PDF ↗ |
| K891688 | COIL AND COIL DELIVERY SYSTEM | Target Therapeutics | 1989-09-22 | Traditional | PDF ↗ |
| K871047 | RADIOPAQUE SPHERICAL EMBOLI (RSE) | Interventional Therapeutics Corp. | 1987-05-22 | Traditional | PDF ↗ |
Product code HCG · Class II · Neurology. Data: openFDA.