FDA Product Code
FDA Product Code KRD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3300
510(k) Clearances — 132 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093813 | OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE | Imbiotechnologies | 2010-05-10 | Traditional | PDF ↗ |
| K093002 | AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 | MicroVention, Inc. | 2009-10-28 | Special | PDF ↗ |
| K091882 | AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM | MicroVention, Inc. | 2009-07-08 | Special | PDF ↗ |
| K090624 | COOK MREYE EMBOLIZATION COILS | Cook, Inc. | 2009-04-02 | Special | PDF ↗ |
| K090046 | CONCERTO DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2009-02-27 | Special | PDF ↗ |
| K083091 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | Biocompatibles UK Limited | 2008-12-24 | Traditional | PDF ↗ |
| K073417 | EMBOZENE MICROSPHERES | Celonova Biosciences, Inc. | 2008-12-15 | Traditional | PDF ↗ |
| K081465 | AXIUM DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. | 2008-08-19 | Traditional | PDF ↗ |
| K073544 | PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES | Rj Medical, Inc. | 2008-03-05 | Traditional | PDF ↗ |
| K071939 | HYDROCOIL EMBOLIC SYSTEMS (HES) | MicroVention, Inc. | 2008-01-11 | Traditional | PDF ↗ |
| K071699 | AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 | Aga Medical Corp. | 2007-08-15 | Special | PDF ↗ |
| K071125 | AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 | Aga Medical Corp. | 2007-06-18 | Special | PDF ↗ |
| K063619 | FLIPPER DETACHABLE EMBOLIZATION COILS | Cook, Inc. | 2006-12-20 | Special | PDF ↗ |
| K052742 | HEPASPHERE MICROSPHERES | Biosphere Medical, Inc. | 2006-11-07 | Traditional | PDF ↗ |
| K061790 | PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES | Protein Polymer Technologies, Inc. | 2006-09-19 | Traditional | PDF ↗ |
| K060078 | FIBERED IDC OCCLUSION SYSTEM | Boston Scientific Corporation | 2006-01-31 | Special | PDF ↗ |
| K052834 | MREYE EMBOLIZATION COIL | Cook, Inc. | 2005-11-23 | Traditional | PDF ↗ |
| K050470 | CONCENTRIC EMBOLIC PEARLS | Concentric Medical, Inc. | 2005-05-06 | Traditional | PDF ↗ |
| K043371 | BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER | Biomerix Corporation | 2005-02-03 | Traditional | PDF ↗ |
| K040342 | INTERLOCKING DETACHABLE COIL SYSTEM (IDC) | Boston Scientific Corp | 2004-04-13 | Traditional | PDF ↗ |
| K034068 | CONTOUR SE MICROSPHERES | Boston Scientific Corp | 2004-03-26 | Traditional | PDF ↗ |
| K031810 | AMPLATZER VASCULAR PLUG | Aga Medical Corp. | 2003-09-09 | Traditional | PDF ↗ |
| K993455 | FLIPPER DETACHABLE EMBOLIZATION COIL | Cook, Inc. | 2000-01-11 | Traditional | PDF ↗ |
| K992121 | EMBOLIZATION COIL SYSTEM | Cook, Inc. | 1999-12-20 | Traditional | PDF ↗ |
| K964112 | BERENSTEIN COIL | Target Therapeutics | 1997-02-26 | Traditional | PDF ↗ |
| K955293 | FIBERED PLATINUM COIL, .035 TYPE | Target Therapeutics | 1996-02-06 | Traditional | PDF ↗ |
| K940189 | COIL POSITIONER SET | Cook, Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K940982 | ARTERIAL EMBOLIZATION DEVICE (KRD) | Cook, Inc. | 1994-10-14 | Traditional | PDF ↗ |
| K914786 | TARGET THERAPEUTICS COILS | Target Therapeutics | 1992-04-20 | Traditional | PDF ↗ |
| K892446 | SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02 | Shiley, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K882136 | INTERSEPT* OXYGEN GAS LINE FILTER | Medtronic Blood Systems, Inc. | 1988-08-11 | Traditional | PDF ↗ |
| K854273 | SILICONE OIL 350 CNETISTOKE | Pacific Medical Industries | 1985-11-22 | Traditional | PDF ↗ |
Product code KRD · Class II · Cardiovascular. Data: openFDA.