Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- DSTClip, Vena-Cava2Product Code
- DSWBag, Polymeric Mesh, Pacemaker1Product Code
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2Product Code
- DSZPacemaker Battery3Product Code
- DTATester, Pacemaker Electrode Function2Product Code
- DTBPermanent Pacemaker Electrode3Product Code
- DTCAnalyzer, Pacemaker Generator Function2Product Code
- DTDPacemaker Lead Adaptor2Product Code
- DTEPulse-Generator, Pacemaker, External2Product Code
- DTFTools, Pacemaker Service1Product Code
- DTGMagnet, Test, Pacemaker1Product Code
- DTISizer, Heart-Valve, Prosthesis1Product Code
- DTJHolder, Heart-Valve, Prosthesis1Product Code
- DTKFilter, Intravascular, Cardiovascular2Product Code
- DSPSystem, Balloon, Intra-Aortic And Control2Product Code
- DSRStimulator, Carotid Sinus Nerve3Product Code
- DSSClip, Vascular2Product Code
- DXYImplantable Pacemaker Pulse-Generator3Product Code
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2Product Code
- DYEReplacement Heart-Valve3Product Code
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter2Product Code
- KFJMaterials, Repair Or Replacement, Pacemaker3Product Code
- KRDDevice, Vascular, For Promoting Embolization2Product Code
- K253376OBSIDIO™ Conformable Embolic (M0013972101010)2Cleared 510(K)
- K250209Polyvinyl Alcohol Embolic Microspheres2Cleared 510(K)
- K250133HARBOR Occlusion Device2Cleared 510(K)
- K251383Prestige Coil System (Prestige Packing Line Extension)2Cleared 510(K)
- K250971Embosphere Microspheres2Cleared 510(K)
- K250276Nitinol Enhanced Device (NED)2Cleared 510(K)
- K250079Ruby XL System2Cleared 510(K)
- K242608Embozene Color-Advanced Microspheres2Cleared 510(K)
- K240873TEMBO Embolic System2Cleared 510(K)
- K242794ONCOZENE Microspheres2Cleared 510(K)
- K242507OBSIDIO™ Conformable Embolic2Cleared 510(K)
- K232934Sunsphere2Cleared 510(K)
- K240261Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)2Cleared 510(K)
- K234123Easi-Vue® embolic microspheres System2Cleared 510(K)
- K231554UniPearls® Embolic Microspheres2Cleared 510(K)
- K230706EMBOLD™ Soft Detachable Coil System2Cleared 510(K)
- K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)2Cleared 510(K)
- K220567Easi-Vue embolic microspheres System2Cleared 510(K)
- K213385GEM2Cleared 510(K)
- K220383LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)2Cleared 510(K)
- K213398EMBOLD Fibered Detachable Coil System2Cleared 510(K)
- K220699Prestige Coil System2Cleared 510(K)
- K213200Solus Gold Embolization Device2Cleared 510(K)
- K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS2Cleared 510(K)
- K212817Merit Siege Vascular Plug2Cleared 510(K)
- K210562HRSpheres Narrow-Size Embolic Microspheres2Cleared 510(K)
- K202850Concerto Versa, Detachable Coil2Cleared 510(K)
- K203025LOBO Vascular Occlusion System (model LOBO-5)2Cleared 510(K)
- K191680AZUR Vascular Plug2Cleared 510(K)
- K200083EMBA Hourglass Peripheral Embolization Device (PED)2Cleared 510(K)
- K191532The Caterpillar and Caterpillar Micro Arterial Embolization Devices2Cleared 510(K)
- K192480Torpedo Gelatin Foam2Cleared 510(K)
- K192083Okami Medical LOBO Vascular Occlusion System2Cleared 510(K)
- K183120EmboCube Embolization Gelatin2Cleared 510(K)
- K183578Torpedo Gelatin Foam2Cleared 510(K)
- K182390IMPEDE-FX Embolization Plug2Cleared 510(K)
- K182944Dr. Amplatz Micro Plug2Cleared 510(K)
- K181021EmboCube Embolization Gelatin2Cleared 510(K)
- K181300Embosphere Microspheres2Cleared 510(K)
- K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm2Cleared 510(K)
- K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume2Cleared 510(K)
- K171946Gel-Bead2Cleared 510(K)
- K172372QuadraSphere Microspheres2Cleared 510(K)
- K171845EMBA Hourglass Peripheral Embolization Device2Cleared 510(K)
- K162524AZUR CX Detachable 18 Peripheral Coil System2Cleared 510(K)
- K162373LC Bead LUMI2Cleared 510(K)
- K160219Hilal Embolization MicroCoils2Cleared 510(K)
- K153778Nester Embolization Coils, Tornado Embolization Coils2Cleared 510(K)
- K150876Bead Block2Cleared 510(K)
- K150870HydroPearl Microspheres, HydroPearl Microspheres2Cleared 510(K)
- K150964MReye Flipper Detachable Embolization Coil and Delivery System2Cleared 510(K)
- K150931MReye Embolization Coils2Cleared 510(K)
- K152157LC Bead LUMI2Cleared 510(K)
- K153102QuadraSphere Microspheres2Cleared 510(K)
- K151358AZUR CX Detachable 35 Coils2Cleared 510(K)
- K150402Endoluminal Occlusion System-EOS2Cleared 510(K)
- K150958LifePearl Microshperes2Cleared 510(K)
- K151187QuadraSphere Microspheres2Cleared 510(K)
- K151676Retracta Detachable Embolization Coil2Cleared 510(K)
- K150108Reverse Medical Micro Vascular Plug System2Cleared 510(K)
- K133924ENDOLUMINAL OCCLUSION SYSTEM (EOS)2Cleared 510(K)
- K140796MEDUSA VASCULAR PLUG,2Cleared 510(K)
- K143038Gel-Block 10X embolization pledgets2Cleared 510(K)
- K141378IDC INTERLOCKING DETACHABLE COIL2Cleared 510(K)
- K141209EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES2Cleared 510(K)
- K141313REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM2Cleared 510(K)
- K133237GEL-BEAD EMBOLIZATION SPHERES2Cleared 510(K)
- K133626AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 352Cleared 510(K)
- K133282REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM2Cleared 510(K)
- K133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM2Cleared 510(K)
- K132083AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 352Cleared 510(K)
- K123696MEDUSA VASCULAR PLUG2Cleared 510(K)
- K132675EMBOZENE MICROSPHERES2Cleared 510(K)
- K132578INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM2Cleared 510(K)
- K123803REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM2Cleared 510(K)
- K130577AZUR PUSHABLE 18 & 35 SYSTEM2Cleared 510(K)
- K130307ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE2Cleared 510(K)
- K123712RETRACTA DETACHABLE EMBOLIZATION COIL2Cleared 510(K)
- K123384AZUR CX DETACHABLE 182Cleared 510(K)
- K122543AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 352Cleared 510(K)
- K122316AZUR DETACHABLE 352Cleared 510(K)
- K113658AMPLATZER VASCULAR PLUG 42Cleared 510(K)
- K113266GEL-BLOCK EMBOLIZATION PLEDGETS2Cleared 510(K)
- K120816INZONE DETACHMENT SYSTEM2Cleared 510(K)
- K120630AZUR DETACHABLE 182Cleared 510(K)
- K113651INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM2Cleared 510(K)
- K112103INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM2Cleared 510(K)
- K111307AZUR DETACHABLE 35 PLATINUM COIL SYSTEM2Cleared 510(K)
- K110295INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM2Cleared 510(K)
- K102912INTERLOCK FIBERED IDC OCCLUSION SYSTEM2Cleared 510(K)
- K102714COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL2Cleared 510(K)
- K102365MICROPLEX COIL SYSTEM- COSMOS2Cleared 510(K)
- K091952ACTA VESSEL OCCLUSION SYSTEM (VOS)2Cleared 510(K)
- K093813OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE2Cleared 510(K)
- K093002AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-4506102Cleared 510(K)
- K091882AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM2Cleared 510(K)
- K090624COOK MREYE EMBOLIZATION COILS2Cleared 510(K)
- K090046CONCERTO DETACHABLE COIL SYSTEM2Cleared 510(K)
- K083091LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES2Cleared 510(K)
- K073417EMBOZENE MICROSPHERES2Cleared 510(K)
- K081465AXIUM DETACHABLE COIL SYSTEM2Cleared 510(K)
- K073544PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES2Cleared 510(K)
- K071939HYDROCOIL EMBOLIC SYSTEMS (HES)2Cleared 510(K)
- K071699AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-0222Cleared 510(K)
- K071125AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-0162Cleared 510(K)
- K063619FLIPPER DETACHABLE EMBOLIZATION COILS2Cleared 510(K)
- K052742HEPASPHERE MICROSPHERES2Cleared 510(K)
- K061790PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES2Cleared 510(K)
- K060078FIBERED IDC OCCLUSION SYSTEM2Cleared 510(K)
- K052834MREYE EMBOLIZATION COIL2Cleared 510(K)
- K050470CONCENTRIC EMBOLIC PEARLS2Cleared 510(K)
- K043371BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER2Cleared 510(K)
- K040342INTERLOCKING DETACHABLE COIL SYSTEM (IDC)2Cleared 510(K)
- K034068CONTOUR SE MICROSPHERES2Cleared 510(K)
- K031810AMPLATZER VASCULAR PLUG2Cleared 510(K)
- K993455FLIPPER DETACHABLE EMBOLIZATION COIL2Cleared 510(K)
- K992121EMBOLIZATION COIL SYSTEM2Cleared 510(K)
- K964112BERENSTEIN COIL2Cleared 510(K)
- K955293FIBERED PLATINUM COIL, .035 TYPE2Cleared 510(K)
- K940189COIL POSITIONER SET2Cleared 510(K)
- K940982ARTERIAL EMBOLIZATION DEVICE (KRD)2Cleared 510(K)
- K914786TARGET THERAPEUTICS COILS2Cleared 510(K)
- P780011MINI BALLOON2PMA Approval
- K892446SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-022Cleared 510(K)
- P780011MINI BALLOON2PMA Approval
- K882136INTERSEPT* OXYGEN GAS LINE FILTER2Cleared 510(K)
- P780011MINI BALLOON2PMA Approval
- K854273SILICONE OIL 350 CNETISTOKE2Cleared 510(K)
- P780011MINI BALLOON2PMA Approval
- P780011MINI BALLOON2PMA Approval
- P780011MINI BALLOON2PMA Approval
- P780011MINI BALLOON2PMA Approval
- P780011MINI-BALLOON DETACHABLE BALLOON SYSTEM2PMA Approval
- P780011MINI BALLOON2PMA Approval
- P780011MINI BALLOON2PMA Approval
- KREAnalyzer, Pacemaker Generator Function, Indirect2Product Code
- KRFCharger, Pacemaker1Product Code
- KRGProgrammer, Pacemaker3Product Code
- KRHRing, Annuloplasty2Product Code
- LDFElectrode, Pacemaker, Temporary2Product Code
- MABMarker, Cardiopulmonary Bypass (Vein Marker)2Product Code
- MALGraft, Vascular, Synthetic/Biologic Composite2Product Code
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries2Product Code
- MOPRotator, Prosthetic Heart Valve1Product Code
- MZYGraft, Vascular, Stainless Steel Tunneler2Product Code
- NHWElectrode, Pacing And Cardioversion, Temporary, Epicardial2Product Code
- NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed3Product Code
- OKRVentricular Bypass (Assist) Device3Product Code
- OMHPericardial Patch To Facilitate Revision Surgeries2Product Code
- OMRVessel Guard Or Cover2Product Code
- OTDEndovascular Suturing System2Product Code
- OVJPulse Generator, External Pacemaker, Dual Chamber2Product Code
- PALPulmonic Replacement Heart ValveFProduct Code
- PCKPediatric Ventricular Assist DeviceFProduct Code
- PNJLeadless Pacemaker3Product Code
- PNSShort-Term Intravascular Filter Catheter2Product Code
- PSQIntracardiac Patch Or Pledget, Biologically Derived2Product Code
- PSTAortic Annuloplasty Ring2Product Code
- QABPacing System Analyzer2Product Code
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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EmboCube Embolization Gelatin
- Page Type
- Cleared 510(K)
- 510(k) Number
- K181021
- 510(k) Type
- Traditional
- Applicant
- Biosphere Medical, S.A.
- Country
- France
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/27/2018
- Days to Decision
- 163 days
- Submission Type
- Summary