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
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- DRKDc-Defibrillator, High Energy, (Including Paddles)3Product Code
- DRLTester, Defibrillator2Product Code
- DRMCompressor, Cardiac, External2Product Code
- DRNDevice, Counter-Pulsating, External2Product Code
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2Product Code
- DRPTourniquet, Automatic Rotating2Product Code
- DWJSystem, Thermal Regulating2Product Code
- DXECatheter, Embolectomy2Product Code
- DXFCatheter, Septostomy2Product Code
- JOWSleeve, Limb, Compressible2Product Code
- K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention System2Cleared 510(K)
- K240499ARTAIRA Arterial Compression Device (AACD01)2Cleared 510(K)
- K241746UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF2Cleared 510(K)
- K232640Venowave VW52Cleared 510(K)
- K240125Therm-X (Home); Therm-X (AT)2Cleared 510(K)
- K234155Nimbl (model PD08-N1)2Cleared 510(K)
- K232270DVT Motion Pneumatic Compression Device2Cleared 510(K)
- K240011Lymphedema Compression2Cleared 510(K)
- K223228Dayspring2Cleared 510(K)
- K232300ElastiMed SACS2Cleared 510(K)
- K231801MedHealth DVT compression Devices MHH900S/MHH900E2Cleared 510(K)
- K222823AeroDVx Arm System2Cleared 510(K)
- K232006LEGACY® IPC2Cleared 510(K)
- K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly2Cleared 510(K)
- K222158Capiflo 50012Cleared 510(K)
- K223195AIROS 6P Sequential Compression Device2Cleared 510(K)
- K223193AIROS 8P Sequential Compression Device2Cleared 510(K)
- K221654medi pneumatic compression system (pcs)-genius (Model 652)2Cleared 510(K)
- K213577VenAir, Sequential Compression System2Cleared 510(K)
- K220761CIRCUL8 Connect DVT Prevention Device2Cleared 510(K)
- K214053Amputee Garment for use with Lympha Press Optimal Plus2Cleared 510(K)
- K213313Veinoflow SCD (Model: LBTK-M-I 5006)2Cleared 510(K)
- K211937SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System2Cleared 510(K)
- K212731Circul8 Pro2Cleared 510(K)
- K203746Venen-trainer (Model: FM150, SFM90)2Cleared 510(K)
- K212287Dayspring Lite2Cleared 510(K)
- K211235CIRCUL8 Luxe DVT Prevention Device2Cleared 510(K)
- K211200WoundExpress2Cleared 510(K)
- K211253PlasmaWave2Cleared 510(K)
- K210417Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL2Cleared 510(K)
- K203847Reprocessed Tri Pulse Compression Garment2Cleared 510(K)
- K210885Dayspring2Cleared 510(K)
- K203353DVT-PRO2Cleared 510(K)
- K203310SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System2Cleared 510(K)
- K203417DVT-4000S2Cleared 510(K)
- K203052Movement and Compressions System (the MAC System)2Cleared 510(K)
- K193662Ezlymph, Ezlymph M2Cleared 510(K)
- K202839Overlapped Compression Therapy2Cleared 510(K)
- K203178Flexitouch Plus System2Cleared 510(K)
- K203016DVT-26002Cleared 510(K)
- K201532B&J DVT Calf/Thigh Garments, Models 801/830 Series2Cleared 510(K)
- K201547B&J DVT Foot Garments, Models 820 Series2Cleared 510(K)
- K193476VariLymph 12 pro2Cleared 510(K)
- K200353ManaFlow2Cleared 510(K)
- K200568B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System2Cleared 510(K)
- K200154B&J DVT Compression Devices MHH800/MHH800SQ2Cleared 510(K)
- K200285VenaOne2Cleared 510(K)
- K192337Zeroveno2Cleared 510(K)
- K193288Koya Ripple2Cleared 510(K)
- K200564Aria System2Cleared 510(K)
- K191856Compression Therapy Device2Cleared 510(K)
- K191937Ezvena IPC, Ezvena SQS2Cleared 510(K)
- K193068AIROS 8 Sequential Compression Device2Cleared 510(K)
- K193069AIROS 6 Sequential Compression Device2Cleared 510(K)
- K193020VenaPro Vascular Therapy System2Cleared 510(K)
- K191107Plexus2Cleared 510(K)
- K190975Plexus SCD110 Sequential Compression Device Sleeve2Cleared 510(K)
- K183349AeroDVx System2Cleared 510(K)
- K190976Radial Medical Compression System2Cleared 510(K)
- K190423Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System2Cleared 510(K)
- K182003Lympha Press Optimal Plus2Cleared 510(K)
- K182578Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device2Cleared 510(K)
- K183631medi pneumatic compression system (pcs) – brio (Model 651)2Cleared 510(K)
- K183328Pulse Rx 2.0, Pulse Pro Rx 2.02Cleared 510(K)
- K182150Devon 52 Sequential Compression Device2Cleared 510(K)
- K181651Radial Medical Compression System2Cleared 510(K)
- K180248VascuEase IC-1200-WH2Cleared 510(K)
- K181217VesoFlow Lite DVT Compression Device2Cleared 510(K)
- K180389Venera 508 Deep Vein Thrombosis (DVT) Prevention System2Cleared 510(K)
- K172770AIROS 6 Sequential Compression Device2Cleared 510(K)
- K172779AIROS 8 Sequential Compression Device2Cleared 510(K)
- K173012ANGIO-PRESS LITE DVT Compression Device2Cleared 510(K)
- K172103Flowtron DVT5 Small Calf Garment2Cleared 510(K)
- K173528Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System2Cleared 510(K)
- K172030Devon 512Cleared 510(K)
- K172277Phlebo Press DVT Model2Cleared 510(K)
- K170415Medline Hemo-Force DVT Compression Sleeve2Cleared 510(K)
- K171793Sequential Circulator SC-2004FC-OC2Cleared 510(K)
- K170814Devon 242Cleared 510(K)
- K170658Lympha Press Optimal Plus2Cleared 510(K)
- K170216Flexitouch System2Cleared 510(K)
- K162481RF1400 Active Compression Wrap2Cleared 510(K)
- K163620Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves2Cleared 510(K)
- K163055Reprocessed Kendall SCD Express Foot Cuff2Cleared 510(K)
- K160180Intermittent Pneumatic Compression system2Cleared 510(K)
- K161105Reprocessed Compression Garments2Cleared 510(K)
- K160431ActiveCare Home2Cleared 510(K)
- K161346NormaTec PCD-T and PCD-B2Cleared 510(K)
- K161209Cirona 64002Cleared 510(K)
- K150980Venous Assist System2Cleared 510(K)
- K152228Hydroven 12, Hydroven 12 Garments2Cleared 510(K)
- K160318PlasmaFlow2Cleared 510(K)
- K150806PulseFlowDF2Cleared 510(K)
- K151158ALP VasQcare Take Home System2Cleared 510(K)
- K151189Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System2Cleared 510(K)
- K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare2Cleared 510(K)
- K150953Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC2Cleared 510(K)
- K143202ANGIO-PRESS DVT Compression Device Model Name: IPCS2Cleared 510(K)
- K143438Flowtron ACS9002Cleared 510(K)
- K143185entré Model PD08-U2Cleared 510(K)
- K143317Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)2Cleared 510(K)
- K143166Medline ReNewal Reprocessed Compression Limb Sleeves2Cleared 510(K)
- K142772Phlebo Press DVT 6032Cleared 510(K)
- K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category)2Cleared 510(K)
- K141064VESOFLOW PLUS DVT COMPRESSION DEVICE2Cleared 510(K)
- K141390INTERMITTENT PNEUMATIC COMPRESSION DEVICE2Cleared 510(K)
- K142640Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator2Cleared 510(K)
- K141609PULSTAR LOGIX PUMP2Cleared 510(K)
- K140813REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES2Cleared 510(K)
- K141578DEVON CIRONA 6200 DVT2Cleared 510(K)
- K131416NOVOPRESS2Cleared 510(K)
- K141360TRIPLEPLAY PRO2Cleared 510(K)
- K140642PCD 737A2Cleared 510(K)
- K140755ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS2Cleared 510(K)
- K140092CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)2Cleared 510(K)
- K133119FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS2Cleared 510(K)
- K133274VENA PRO2Cleared 510(K)
- K131146ARTASSIST AND VENASSIST2Cleared 510(K)
- K131387WRIGHT GRADIENT 52 - TORSO2Cleared 510(K)
- K131420PETITE BASIC SYSTEM 701 ELT2Cleared 510(K)
- K132360KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER2Cleared 510(K)
- K123830INTERMITTENT PNEUMATIC COMPRESSION DEVICE2Cleared 510(K)
- K131306IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE2Cleared 510(K)
- K131327BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM2Cleared 510(K)
- K131046VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)2Cleared 510(K)
- K131743CIRONA DVT FOOT GARMENT2Cleared 510(K)
- K130722AIRCAST VENAFLOW ELITE SYSTEM2Cleared 510(K)
- K131193ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM2Cleared 510(K)
- K130174DVTCARE CA52Cleared 510(K)
- K130571DEVON CIRONA 6100 DVT2Cleared 510(K)
- K123959CIRCUFLOW 51502Cleared 510(K)
- K122640VPULSE2Cleared 510(K)
- K123647CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE2Cleared 510(K)
- K123308PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM2Cleared 510(K)
- K122873VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS2Cleared 510(K)
- K122609VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F2Cleared 510(K)
- K122330FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE2Cleared 510(K)
- K121962PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B2Cleared 510(K)
- K122499AIRCAST VENAFLOW ELITE SYSTEM2Cleared 510(K)
- K122179VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE)2Cleared 510(K)
- K121718A-V FOOT PUMP2Cleared 510(K)
- K121376COMPRESSION CARE FLIGHT2Cleared 510(K)
- K121145RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME2Cleared 510(K)
- K120944KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER2Cleared 510(K)
- K121001COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)2Cleared 510(K)
- K120972FLEXITOUCH SYSTEM2Cleared 510(K)
- K113525ACTIVECARE DVT ACTIVECARE+SFT2Cleared 510(K)
- K112677THE VENOUS ASSIST SYSTEM2Cleared 510(K)
- K111748RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A2Cleared 510(K)
- K112838VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS2Cleared 510(K)
- K110276POWERPRESS UNIT2Cleared 510(K)
- K111720AVIAFIT2Cleared 510(K)
- K112311ALP 501 RB PUMP SYSTEM2Cleared 510(K)
- K110977VESOFLOW2Cleared 510(K)
- K110159ACTIVECARE SFT2Cleared 510(K)
- K110358VENODYNE V8102Cleared 510(K)
- K103113VASCULAIRE COMPRESSION SYSTEM2Cleared 510(K)
- K103187TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM2Cleared 510(K)
- K102940VASCOPRESS SEQUENTIAL DVT PUMP2Cleared 510(K)
- K103247VASCUCOMP2Cleared 510(K)
- K101035WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 20002Cleared 510(K)
- K101355AUGEASE VASCULAR AUGMENTATION DEVICE2Cleared 510(K)
- K102737KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER2Cleared 510(K)
- K102732VASOGRAD DVT COMPRESSION GARMENT2Cleared 510(K)
- K102582ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE2Cleared 510(K)
- K100969WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N2Cleared 510(K)
- K101702MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS2Cleared 510(K)
- K101330MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE2Cleared 510(K)
- K101915VASOPRESS SUPREME MINI MODEL VP500DM2Cleared 510(K)
- K100909REPROCESSED COMPRESSION SLEEVES2Cleared 510(K)
- K101087REPROCESSED RESTEP COMPRESSION SLEEVES2Cleared 510(K)
- K101523CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE2Cleared 510(K)
- K100677LYMPHA PRESS 201MAX, MODEL 201MAX2Cleared 510(K)
- K100521COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS2Cleared 510(K)
- K100306KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES2Cleared 510(K)
- K100446CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE2Cleared 510(K)
- K093658RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS2Cleared 510(K)
- K091700AIRCAST VENAFLOW ELITE SYSTEM2Cleared 510(K)
- K090308RESTEP DVY SYSTEM, MODEL RSP-1012Cleared 510(K)
- K090074HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS2Cleared 510(K)
- K082149LYMPHA PRESS OPTIMAL, MODEL# 1201AP2Cleared 510(K)
- K080551UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE2Cleared 510(K)
- K073028VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-302Cleared 510(K)
- K071763AMADEUS ADAPTIVE COMPRESSION THERAPY2Cleared 510(K)
- K073013CTU676 DEVICE2Cleared 510(K)
- K072372PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE2Cleared 510(K)
- K072666BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM2Cleared 510(K)
- K071744AVIAFIT PULSATING LEGBAND2Cleared 510(K)
- K071040WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS2Cleared 510(K)
- K070324IPC-BOOT2Cleared 510(K)
- K061814VASOPRESS DVT SYSTEM, MODEL VP500D2Cleared 510(K)
- K062818FLEXITOUCH SYSTEM2Cleared 510(K)
- K061967SCD GARMENT, MODEL VP5302Cleared 510(K)
- K061866NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS2Cleared 510(K)
- K061857MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR2Cleared 510(K)
- K061125DVTCARE CA52Cleared 510(K)
- K052691SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES2Cleared 510(K)
- K052243PROACT WITH GEL OR PROACT 12Cleared 510(K)
- K051227RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP12Cleared 510(K)
- K051438VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)2Cleared 510(K)
- K060146ACTIVECARE ++ SYSTEM2Cleared 510(K)
- K060049REPROCESSED COMPRESSION SLEEVES2Cleared 510(K)
- K060091ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES2Cleared 510(K)
- K053575HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS2Cleared 510(K)
- K053316REPROCESSED COMPRESSION SLEEVES2Cleared 510(K)
- K060220PBS MODEL 701A COMPRESSION THERAPY DEVICE2Cleared 510(K)
- K051805KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE2Cleared 510(K)
- K050584GS-128 GRADIENT COMPRESSION SYSTEM2Cleared 510(K)
- K043423MODEL SC-3008 SEQUENTIAL CIRCULATOR2Cleared 510(K)
- K042217FLOWMEDIC, MODEL 2202Cleared 510(K)
- K041659C-BOOT2Cleared 510(K)
- K040649KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE2Cleared 510(K)
- K040511SCD EXPRESS PORTABLE COMPRESSION SYSTEM2Cleared 510(K)
- K040065JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES2Cleared 510(K)
- K033615WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES2Cleared 510(K)
- K031722JSA REPROCESSED COMPRESSION SLEEVE DEVICES2Cleared 510(K)
- K031559RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES2Cleared 510(K)
- K031189UUHC REPROCESSED COMPRESSION SLEEVE DEVICES2Cleared 510(K)
- K024019ARTERIALFLOW SYSTEM, MODEL 32A2Cleared 510(K)
- K024087REPROCESSED COMPRESSION SLEEVES2Cleared 510(K)
- K024074REPROCESSED COMPRESSION SLEEVES2Cleared 510(K)
- K022340TRAVELAIR PORTABLE COMPRESSION SYSTEM2Cleared 510(K)
- K023800VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 30172Cleared 510(K)
- K021654REPROCESSED COMPRESSION SLEEVE2Cleared 510(K)
- K021509HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 50892Cleared 510(K)
- K023573WIZAIR COMPRESSION SYSTEM2Cleared 510(K)
- K022753REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS2Cleared 510(K)
- K022786DVT602Cleared 510(K)
- K021528REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP2Cleared 510(K)
- K020211BODY FORCE, MODEL BT 60002Cleared 510(K)
- K013297AIRCAST, MODEL #30112Cleared 510(K)
- K012658REPROCESSED COMPRESSION LIMB SLEEVES2Cleared 510(K)
- K012979COMPRESSIBLE LIMB SLEEVE2Cleared 510(K)
- K012614KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN2Cleared 510(K)
- K012657HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP2Cleared 510(K)
- K012651HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 2002Cleared 510(K)
- K012650HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP2Cleared 510(K)
- K012654HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 402Cleared 510(K)
- K012956HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB2Cleared 510(K)
- K012417HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 54802Cleared 510(K)
- K012994WIZAIR DVT2Cleared 510(K)
- K010744FLOWTRON UNIVERSAL, MODEL AC6002Cleared 510(K)
- K012675REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS2Cleared 510(K)
- K012597STERILMED REPROCESSED COMPRESSION SLEEVES2Cleared 510(K)
- K012606CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE2Cleared 510(K)
- K012601CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH2Cleared 510(K)
- K012616CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR2Cleared 510(K)
- K012612CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE2Cleared 510(K)
- K012621CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT2Cleared 510(K)
- K013436NORMATEC PCD2Cleared 510(K)
- K013331LYMPHA PRESS PLUS DEVICE2Cleared 510(K)
- K011192COMPRESSIBLE LIMB SLEEVE2Cleared 510(K)
- K011318VENODYNE DVT ADVANTAGE PLUS2Cleared 510(K)
- K003857STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES2Cleared 510(K)
- K012403VANGUARD REPROCESSED COMPRESSION GARMENT2Cleared 510(K)
- K012008STS RANGE , MODELS STS20,STS30,STS402Cleared 510(K)
- K003828VASO PRESS DVT FOOT GARMENT #VP 5202Cleared 510(K)
- K003701SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)2Cleared 510(K)
- K003284PHLEBOPUMP, MODEL 10002Cleared 510(K)
- K001802VENODYNE DVT ADVANTAGE MODEL 6102Cleared 510(K)
- K002287WIZAIR COMPRESSION SYSTEM2Cleared 510(K)
- K991038VASO PRESS DVT SYSTEM, MODELS VP500, VP5012Cleared 510(K)
- K993758PROAIR 3000 COMPRESSION SYSTEM2Cleared 510(K)
- K000303HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB2Cleared 510(K)
- K000147CTC DVT-1 CALF GARMENT, MODEL DVT-12Cleared 510(K)
- K992454VENAFLOW SYSTEM, MODEL 30A2Cleared 510(K)
- K992079KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 73252Cleared 510(K)
- K973592WALKCARE P200 SYSTEM2Cleared 510(K)
- K983680TRINITY II SINGLE CHAMBER DVT PUMP2Cleared 510(K)
- K981311COWBOY XV2Cleared 510(K)
- K974393VASO PRESS SYSTEM2Cleared 510(K)
- K981643RTM DVT PROSOFT CUFF MODEL NUMBER PS1002Cleared 510(K)
- K980600D903 AVANT ADULT HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K971892BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 6512Cleared 510(K)
- K980456JOBST ATHROMBIC PUMP SYSTEM 26002Cleared 510(K)
- K974318HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB2Cleared 510(K)
- K965153HUNTLEIGH FP5000 SYSTEM MODEL FP50002Cleared 510(K)
- K970922JOBST ATHROMBIC PUMP/SLEEVE2Cleared 510(K)
- K963957TRINITY DVT SYSTEM2Cleared 510(K)
- K964238AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS2Cleared 510(K)
- K970014TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)2Cleared 510(K)
- K964425A-V IMPULSE SYSTEM MODEL 60602Cleared 510(K)
- K964188HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT2Cleared 510(K)
- K961676AIRCAST VENAFLOW SYSTEM (MODIFICATION)2Cleared 510(K)
- K963067SOF. PRESS EPC 51 SYSTEM2Cleared 510(K)
- K963929JOBST ATHROMBIC PUMP SYSTEM 21002Cleared 510(K)
- K963672MODEL 90022 ROLLING STAND2Cleared 510(K)
- K961405ALBA HEALTH PAS WRAP SYSTEM2Cleared 510(K)
- K961797WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE2Cleared 510(K)
- K961891WLP SINGLE-SEGMENT VERSION WLP SOLO VII2Cleared 510(K)
- K961292WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL2Cleared 510(K)
- K954788EUREDUC PNEUMATIC DRAINAGE SYSTEM2Cleared 510(K)
- K961166FLOWTRON EXCEL PUMP2Cleared 510(K)
- K960902EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP032Cleared 510(K)
- K955853HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM2Cleared 510(K)
- K950967M.I.C.2Cleared 510(K)
- K953850REDOX2Cleared 510(K)
- K942530ART-ASSIST MODEL AA-10002Cleared 510(K)
- K954489TRINITY SLEEVE(S)2Cleared 510(K)
- K953648A-V IMPULSE SYSTEM MODEL 60602Cleared 510(K)
- K951683A-V IMPULSE SYSTEM MODEL 60602Cleared 510(K)
- K951684AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)2Cleared 510(K)
- K944567COWBOY X2Cleared 510(K)
- K942796PRESSSION S III2Cleared 510(K)
- K942664KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM2Cleared 510(K)
- K943392THERA-FLOW GRADIENT SEQUENTIAL PUMP2Cleared 510(K)
- K943287ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMP2Cleared 510(K)
- K934639JOBST ATHROMBIC PUMP - SYSTEM 25002Cleared 510(K)
- K933977AIRCAST EDEMAFLOW SYSTEM2Cleared 510(K)
- K930526INTERMITTENT COMPRESSION SYSTEM MODEL 50002Cleared 510(K)
- K932900AIRCAST VENAFLOW SYSTEM2Cleared 510(K)
- K933259SCD(R) CONTROLLER2Cleared 510(K)
- K932835KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE2Cleared 510(K)
- K932215COWBOY III2Cleared 510(K)
- K924891PLEXUS PULSER I, PLEXUS PULSER II2Cleared 510(K)
- K925717CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE2Cleared 510(K)
- K921608PRESSSION, SEQUENTIAL2Cleared 510(K)
- K920308COWBOY II2Cleared 510(K)
- K921562JOBST EXTREMITY PUMP SYSTEM 75002Cleared 510(K)
- K914461A-V IMPULSE SYSTEM2Cleared 510(K)
- K913611COWBOY2Cleared 510(K)
- K911853PULSATILE ANTI-EMBOLISM SYS.PUMP2Cleared 510(K)
- K910188FLOWPLUS AC330 PUMP GARMENTS2Cleared 510(K)
- K903894VENAPULSE MODELS VP-25 AND VP-502Cleared 510(K)
- K904267ZOEX ANTISHOCK TROUSERS2Cleared 510(K)
- K895732JOBST ATHROMBIC PUMP(R) SYSTEM 20002Cleared 510(K)
- K895278SCD KNEE IMMOBILIZER2Cleared 510(K)
- K890938KENDALL SCD THERAPEUTIC SYSTEM2Cleared 510(K)
- K881632FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT2Cleared 510(K)
- K882683JOBST EXTREMITY PUMP(R) SYSTEM 75002Cleared 510(K)
- K873997ANTI-SHOCK TROUSERS2Cleared 510(K)
- K863581MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB2Cleared 510(K)
- K841235MEDO MEDOMER MBF-100 II2Cleared 510(K)
- K830577LINEAR PUMP #43709752Cleared 510(K)
- K821696THE SOFT PEDAL2Cleared 510(K)
- K810338LYMPHA PRESS2Cleared 510(K)
- K800337DVT PREVENTION SYS. MBE 22 PRESSURE U.2Cleared 510(K)
- K7918943M BRAND TOTAL LEG COMPRESSION TLC SYS.2Cleared 510(K)
- K781358SEQUENTIAL CUFF INFLATION DEVICE2Cleared 510(K)
- K781357T.E.D. SEQUENTIAL COMPRESSION SLEEVES2Cleared 510(K)
- K770956PAS ANTI-EMBOLISM SYSTEM2Cleared 510(K)
- K771083SEQUENTIAL PRESSURE CUFF2Cleared 510(K)
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)2Product Code
- LHXTrousers, Anti-Shock2Product Code
- LIXAid, Cardiopulmonary Resuscitation2Product Code
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous2Product Code
- MKJAutomated External Defibrillators (Non-Wearable)3Product Code
- MMXDevice, Percutaneous Retrieval2Product Code
- MPCAtrial Defibrillator3Product Code
- MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator2Product Code
- MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker2Product Code
- NSAOver-The-Counter Automated External Defibrillator3Product Code
- NZEHyperthermia Monitor2Product Code
- PJBCatheter Remote Control System2Product Code
- PLAEsophageal Thermal Regulation And Gastric Suctioning Device2Product Code
- PMJCpr Aid Feedback Device (No Software)2Product Code
- PMKCpr Aid Device Without Feedback1Product Code
- PPSSleeve, Head And Neck, Compressible2Product Code
- QEWPeripheral Mechanical Thrombectomy With Aspiration2Product Code
- QEXCoronary Mechanical Thrombectomy With Aspiration2Product Code
- QEYMechanical Thrombolysis Catheter2Product Code
- QEZAspiration Thrombectomy Catheter2Product Code
- QLZSeptostomy Catheter, Reprocessed2Product Code
- QMSAdjunctive Open Loop Fluid Therapy Recommender2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
CIRCUL8 Luxe DVT Prevention Device
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K211235
- 510(k) Type
- Traditional
- Applicant
- Ortho8 Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/8/2021
- Days to Decision
- 135 days
- Submission Type
- Summary