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
- K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr2Cleared 510(K)
- K251446PlasmaFlow X Compression Sleeve Device (XPF0001)2Cleared 510(K)
- K251086PnueAira (PNCU-01)2Cleared 510(K)
- K250817Coretech Compression System (Coretech RHB3003)2Cleared 510(K)
- 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)
- K223193AIROS 8P Sequential Compression Device2Cleared 510(K)
- K223195AIROS 6P 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)
- 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)
- K012657HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP2Cleared 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)
- K012601CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH2Cleared 510(K)
- K012606CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE2Cleared 510(K)
- K012612CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE2Cleared 510(K)
- K012616CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR2Cleared 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
Kendall 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 Assembly
- Page Type
- Cleared 510(K)
- 510(k) Number
- K230028
- 510(k) Type
- Traditional
- Applicant
- Cardinal Health200, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/3/2023
- Days to Decision
- 89 days
- Submission Type
- Statement