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)
Top companies in HCG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2007 | K070656 | HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Jun 1, 2007 | K071246 | MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR Micrus Endovascular Corporation | HCG |
| Apr 24, 2007 | K060747 | FX DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | HCG |
| Apr 6, 2007 | K070707 | MICRUS MICROCOIL SYSTEM Micrus Endovascular Corporation | HCG |
| Jan 17, 2007 | K063653 | MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC Micrus Endovascular Corporation | HCG |
| Dec 11, 2006 | K052509 | M-BOLUS EMBOLIC MICROSPHERES Scion Cardio-Vascular, Inc. | HCG |
| Dec 7, 2006 | K063254 | THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Cordis Neurovascular, Inc. | HCG |
| Aug 25, 2006 | K062036 | MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 Micrus Endovascular Corporation | HCG |
| Apr 20, 2006 | K060625 | NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR Micro Therapeutics, Inc. | HCG |
| Jan 30, 2006 | K053548 | MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES Protein Polymer Technologies, Inc. | HCG |
| Dec 15, 2005 | K053197 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION Cordis Neurovascular, Inc. | HCG |
| Dec 7, 2005 | K053160 | MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE Micrus Endovascular Corporation | HCG |
| Jun 28, 2005 | K051560 | NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR Micro Therapeutics, Inc. | HCG |
| Jun 28, 2005 | K050954 | MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Jun 22, 2005 | K051425 | NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR Micro Therapeutics, Inc. | HCG |
| Jun 1, 2005 | K042297 | ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES Acta Vascular Systems, Inc. | HCG |
| Apr 27, 2005 | K050543 | NEXUS DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | HCG |
| Apr 15, 2005 | K050700 | MATRIX STRETCH RESISTANT (SR) COILS Boston Scientific Corp | HCG |
| Nov 12, 2004 | K042231 | GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES Biocompatibles UK Limited | HCG |
| Oct 19, 2004 | K042539 | GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL Boston Scientific Corp | HCG |
| Jul 16, 2004 | K041649 | SAPPHIRE NXT DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | HCG |
| Jul 7, 2004 | K041551 | MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Mar 25, 2004 | K040694 | MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) Micro Therapeutics, Inc. | HCG |
| Feb 13, 2004 | K032619 | MICROSTAT PVA FOAM EMBOLIZATION PARTICLES Surgica Corp. | HCG |
| Feb 4, 2004 | K033813 | MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE Micrus Corp. | HCG |
| Feb 4, 2004 | K033761 | GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES Biocompatibles UK Limited | HCG |
| Jan 9, 2004 | K033372 | SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS Micro Therapeutics, Inc. | HCG |
| Dec 30, 2003 | K033836 | HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Nov 28, 2003 | K032872 | MICRUS MICROCOIL SYSTEM Micrus Corp. | HCG |
| Oct 22, 2003 | K032590 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Sep 25, 2003 | K032497 | SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT Micro Therapeutics, Inc. | HCG |
| Sep 23, 2003 | K032707 | CONTOUR SE MICROSPHERES (SYRINGE) Boston Scientific Corp | HCG |
| Sep 23, 2003 | K032553 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Cordis Neurovascular, Inc. | HCG |
| Sep 16, 2003 | K032542 | MODIFICATION TO CONTOUR SE MICROSPHERES Boston Scientific Corp | HCG |
| Aug 20, 2003 | K031852 | SAPPHIRE DETACHABLE FIBER COILS Micro Therapeutics, Inc. | HCG |
| Aug 1, 2003 | K031578 | MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR Micrus Corp. | HCG |
| Aug 1, 2003 | K031049 | GUGLIELMI DETACHABLE COIL (GDC) Boston Scientific, Target | HCG |
| Jul 21, 2003 | K030392 | SAPPHIRE DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. | HCG |
| Jun 20, 2003 | K030963 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Cordis Neurovascular, Inc. | HCG |
| May 14, 2003 | K031168 | MATRIX STRETCH RESISTANT DETACHABLE COIL Boston Scientific, Target | HCG |
| Mar 14, 2003 | K030475 | GDC STRETCH RESISTANT DETACHABLE COIL Boston Scientific, Target | HCG |
| Dec 16, 2002 | K023089 | GELSPHERES EMBOLIC AGENT Biocure, Inc. | HCG |
| Oct 22, 2002 | K022420 | MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 Micrus Corp. | HCG |
| Sep 6, 2002 | K022735 | MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT MicroVention, Inc. | HCG |
| Aug 22, 2002 | K022427 | CONTOUR SE MICROSPHERES Boston Scientific Corp | HCG |
| Jul 29, 2002 | K020434 | MICROPLEX COIL SYSTEM (MCS) MicroVention, Inc. | HCG |
| Jul 9, 2002 | K021914 | MICROPLEX COIL SYSTEMS (MCS) MicroVention, Inc. | HCG |
| Jun 6, 2002 | K021494 | GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 Boston Scientific, Target | HCG |
| May 31, 2002 | K020033 | MAXISTAT PVA FOAM EMBOLIZATION PARTICLES Surgica Corp. | HCG |
| Mar 7, 2002 | K014041 | TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM Cordis Neurovascular | HCG |
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