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
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- BYSOxygenator, Long Term Support Greater Than 6 Hours2Product Code
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2Product Code
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2Product Code
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2Product Code
- K242953KIDS Arterial Filters2Cleared 510(K)
- K242092MICRO Arterial Filters2Cleared 510(K)
- K231362OCS Heart Leukocyte Depleting Filter2Cleared 510(K)
- K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE2Cleared 510(K)
- K122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE2Cleared 510(K)
- K121209TERUMO PALL AL20X ARTERIAL FILTER2Cleared 510(K)
- K112525D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS2Cleared 510(K)
- K100646AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE2Cleared 510(K)
- K093986AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS2Cleared 510(K)
- K093601AF 840 PH.I.S.I.O. ARTERIAL FILTER2Cleared 510(K)
- K090518QUART ARTERIAL FILTER WITH SOFTLINE COATING2Cleared 510(K)
- K083747TERUMO PALL AL3X ARTERIAL FILTER2Cleared 510(K)
- K083834TERUMO PALL AL6X ARTERIAL FILTER2Cleared 510(K)
- K081054GISH ARTERIAL FILTER WITH HA COATING2Cleared 510(K)
- K082544QUART ARTERIAL FILTER WITH BIOLINE COATING2Cleared 510(K)
- K072308D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED2Cleared 510(K)
- K071253AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB40142Cleared 510(K)
- K063255D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED2Cleared 510(K)
- K062429MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH2Cleared 510(K)
- K061546QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 1402Cleared 510(K)
- K052717D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER2Cleared 510(K)
- K052205CAPIOX AF125X ARTERIAL FILTER2Cleared 510(K)
- K051232D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER2Cleared 510(K)
- K041061D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS2Cleared 510(K)
- K040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER2Cleared 510(K)
- K033987D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS2Cleared 510(K)
- K033468AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE2Cleared 510(K)
- K031946EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE2Cleared 510(K)
- K032128TERUMO AL8X ARTERIAL FILTER WITH X-COATING2Cleared 510(K)
- K031323DBT, DYNAMIC BUBBLE TRAP2Cleared 510(K)
- K023833GISH ARTERIAL FILTER WITH GBS COATING2Cleared 510(K)
- K022071EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF40002Cleared 510(K)
- K013084AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T2Cleared 510(K)
- K011804CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X2Cleared 510(K)
- K002493DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER2Cleared 510(K)
- K002026CAPIOX ARTERIAL FILTER2Cleared 510(K)
- K001787QUART ARTERIAL FILTER, MODEL HBF 1402Cleared 510(K)
- K001138AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB3542Cleared 510(K)
- K000379MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB3522Cleared 510(K)
- K994208AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/3542Cleared 510(K)
- K982254COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD2Cleared 510(K)
- K980762PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE2Cleared 510(K)
- K961869DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 402Cleared 510(K)
- K952532AFFINITY ARTERIAL BLOOD FILTER2Cleared 510(K)
- K952270DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN2Cleared 510(K)
- K943917CAPIOX ARTERIAL FILTER2Cleared 510(K)
- K945198DIDECO PEDIATRIC ARTERIAL FILTERS2Cleared 510(K)
- K926413MEDTRONIC ARTERIAL FILTER2Cleared 510(K)
- K914791GISH ARTERIAL FILTER2Cleared 510(K)
- K920594SHILEY PERFUSION TUBING SETS2Cleared 510(K)
- K910935MODIFIED PYROGEN TESTING2Cleared 510(K)
- K902723ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 202Cleared 510(K)
- K902518LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE2Cleared 510(K)
- K900758HEPARINIZED ARTERIAL SCREEN BLOOD FILTER2Cleared 510(K)
- K892387MODIFIED GELMAN ARTERIAL FILTER2Cleared 510(K)
- K882137EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/402Cleared 510(K)
- K873316BUBBLE TRAP-FILTER CAT. NO B180F372Cleared 510(K)
- K880671MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER2Cleared 510(K)
- K875080AIR VENT LINE CAT. NO. AVL-362Cleared 510(K)
- K864262ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING2Cleared 510(K)
- K862609INTERFACE ARTERIAL BLOOD FILTER, MODEL 442Cleared 510(K)
- K862591INTERFACE ARTERIAL BLOOD FILTER, MODEL 422Cleared 510(K)
- K862068GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)2Cleared 510(K)
- K855066SWANK ARTERIAL LINE BLOOD FILTER HF60002Cleared 510(K)
- K853987PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE2Cleared 510(K)
- K851003ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX2Cleared 510(K)
- K842813HEPARIN COATED ARTERIAL BLOOD FILTERS2Cleared 510(K)
- K834382PALL EC PLUS FILTER W/FILTER SLEEVE2Cleared 510(K)
- K834380PALL EC PLUS FILTER2Cleared 510(K)
- K840612PEDIATRIC ARTERIAL BLOOD FILTER2Cleared 510(K)
- K831507LOW TRAUMA ARTERIAL FILTER H-6402Cleared 510(K)
- K833477INTERSEPT 40 MICRON FILTER2Cleared 510(K)
- K833476INTERSEPT 40 MICRON FILTER W/TUBING2Cleared 510(K)
- K833048PURGES LINES, PL-45 & PL-332Cleared 510(K)
- K830132ARTERIAL BLOOD FILTER AF-1040-AF-1040BL2Cleared 510(K)
- K830131ARTERIAL BLOOD FILTER AF-1025-AF-1025BL2Cleared 510(K)
- K823108INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT2Cleared 510(K)
- K823258INTERFACE ARTERIAL BLOOD FILTER #402Cleared 510(K)
- K820044ARTERIAL BLOOD FILTER, #AF-10252Cleared 510(K)
- K820679PEDIATRIC ARTERIAL BLOOD FILTER #AF-5402Cleared 510(K)
- K820343ARTERIAL BLOOD FILTER MODEL #AF-10402Cleared 510(K)
- K820472WILLIAM HARVEY H-625 ARTERIAL FILTER2Cleared 510(K)
- K820045CARDIOVASCULAR DEVICES2Cleared 510(K)
- K812659TERUMO HOLLOW OXYGENATOR CIRCUIT2Cleared 510(K)
- K813131INTERFACE ARTERIAL BLOOD FILTER2Cleared 510(K)
- K812742SHILEY ARTERIAL FILTER W/40 MICRON SCREE2Cleared 510(K)
- K811379SHILEY ARTERIAL FILTER2Cleared 510(K)
- K810068PEDIATRIC ARTERIAL BLOOD FILTER2Cleared 510(K)
- K802755ARTERIAL BLOOD FILTER BF-372Cleared 510(K)
- K802602L-3 PURGE LINE2Cleared 510(K)
- K801147PEDIATRIC ARTERIAL BLOOD FILTER #AF-52Cleared 510(K)
- K792450ARTERIAL BLOOD FILTER, MODEL AF-102Cleared 510(K)
- K791748ULTIPOR BLOOD FILTER EXTRA-CORPOREAL2Cleared 510(K)
- K790435INTERSEPT* BLOOD FILTER W/ TUBING BYPASS2Cleared 510(K)
- K781707FILTER, ARTERIAL BLOOD W/TUBING BYPASS2Cleared 510(K)
- DTNReservoir, Blood, Cardiopulmonary Bypass2Product Code
- DTPDefoamer, Cardiopulmonary Bypass2Product Code
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2Product Code
- DTRHeat-Exchanger, Cardiopulmonary Bypass2Product Code
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass2Product Code
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass2Product Code
- DTXGas Control Unit, Cardiopulmonary Bypass2Product Code
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass2Product Code
- DTZOxygenator, Cardiopulmonary Bypass2Product Code
- DWAControl, Pump Speed, Cardiopulmonary Bypass2Product Code
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type2Product Code
- DWCController, Temperature, Cardiopulmonary Bypass2Product Code
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass2Product Code
- DWETubing, Pump, Cardiopulmonary Bypass2Product Code
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2Product Code
- DWPDilator, Vessel, Surgical2Product Code
- DWQStripper, Vein, External2Product Code
- DWSInstruments, Surgical, Cardiovascular1Product Code
- DWXStripper, Artery, Intraluminal2Product Code
- DWZDevice, Biopsy, Endomyocardial2Product Code
- DXCClamp, Vascular2Product Code
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass2Product Code
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass2Product Code
- JORGenerator, Pulsatile Flow, Cardiopulmonary Bypass3Product Code
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2Product Code
- KRIAccessory Equipment, Cardiopulmonary Bypass1Product Code
- KRJFilter, Prebypass, Cardiopulmonary Bypass2Product Code
- KRLDetector, Bubble, Cardiopulmonary Bypass2Product Code
- LXNProbe, Test, Heart-Valve1Product Code
- MCWCatheter, Peripheral, Atherectomy2Product Code
- MFYEndothelial Cell Harvesting Kit2Product Code
- MGZValvulotome2Product Code
- MJJCpb Check Valve, Retrograde Flow, In-Line2Product Code
- MJNCatheter, Intravascular Occluding, Temporary2Product Code
- MNJValve, Pressure Relief, Cardiopulmonary Bypass2Product Code
- MWSStabilizer, Heart1Product Code
- NCPCannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection2Product Code
- NLJStripper, Vein, External, Reprocessed2Product Code
- NMFClamp, Vascular, Reprocessed2Product Code
- NQGStabilizer, Heart, Non-Compression, Reprocessed1Product Code
- OETCardioplegia Solution Administration Kit2Product Code
- OEUCardiopulmonary Bypass Catheter Kit2Product Code
- OFACardiovascular Surgical Instruments Tray1Product Code
- OFGCt Biopsy Tray2Product Code
- PNQApical Closure Device2Product Code
- PYXTemporary Non-Roller Type Right Heart Support Blood Pump3Product Code
- PTNReservoir, Blood, Cardiopulmonary Bypass, Exempt2Product Code
- PZSDual Lumen Ecmo Cannula2Product Code
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure2Product Code
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use2Product Code
- QOHExtracorporeal System For Carbon Dioxide Removal2Product Code
- QHWSingle Lumen Ecmo Cannula2Product Code
- QTFReprocessed Atherectomy Catheter2Product Code
- QWFTubing, Long Term Support Greater Than 6 Hours2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K031946
- 510(k) Type
- Traditional
- Applicant
- Edwards Lifesciences, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/3/2003
- Days to Decision
- 132 days
- Submission Type
- Summary