Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- K242623Disposable Blood Pressure cuff; Reusable Blood Pressure cuff2Cleared 510(K)
- K240165Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer2Cleared 510(K)
- K233276Reusable Blood Pressure Cuff2Cleared 510(K)
- K232772Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)2Cleared 510(K)
- K231961NIBPCuff2Cleared 510(K)
- K230859Aneroid Sphygmomanometer2Cleared 510(K)
- K230145ONE-CUF2Cleared 510(K)
- K222652Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer2Cleared 510(K)
- K222420Disposable Blood Pressure Cuff2Cleared 510(K)
- K221857Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-2012Cleared 510(K)
- K212416WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX02032Cleared 510(K)
- K211084Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope2Cleared 510(K)
- K211747Reusable NIBP Cuff2Cleared 510(K)
- K203620Aneroid Sphygmomanometer2Cleared 510(K)
- K203652Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D2Cleared 510(K)
- K202543OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip2Cleared 510(K)
- K193259Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer2Cleared 510(K)
- K192500Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer2Cleared 510(K)
- K193629Disposable NIBP Cuff2Cleared 510(K)
- K191253Reusable NIBP Cuff2Cleared 510(K)
- K191209Aneroid Type Blood Pressure Kit2Cleared 510(K)
- K190902RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope2Cleared 510(K)
- K182433Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff2Cleared 510(K)
- K173197Reusable NIBP Cuff2Cleared 510(K)
- K173869Med-link Reusable Blood Pressure Cuff2Cleared 510(K)
- K173246ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K180335Accutension Smartphone Auscultatory Blood2Cleared 510(K)
- K171889Reusable Blood Pressure Cuff2Cleared 510(K)
- K173044Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff2Cleared 510(K)
- K160530Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff2Cleared 510(K)
- K161035Medline Singe Patient Use Blood Pressure Cuff2Cleared 510(K)
- K152006Cogent Hemodynamic Monitoring System2Cleared 510(K)
- K153251Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff2Cleared 510(K)
- K151810Bpump Blood Pressure Cuff2Cleared 510(K)
- K152465Disposable Blood Pressure Cuff2Cleared 510(K)
- K152468Reusable Blood Pressure Cuff2Cleared 510(K)
- K152801ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT2Cleared 510(K)
- K152363Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M2Cleared 510(K)
- K151290Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff2Cleared 510(K)
- K151246Aneroid Sphygmomanometer2Cleared 510(K)
- K143728Minhua Disposable Blood Pressure Cuff2Cleared 510(K)
- K143332Fast Sphyg by Koven2Cleared 510(K)
- K150227Disposable Blood Pressure Cuff Guard2Cleared 510(K)
- K141998SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS2Cleared 510(K)
- K140874GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF2Cleared 510(K)
- K141392SPHYGMOMANOMETER2Cleared 510(K)
- K133117ANDON BLOOD PRESSURE CUFF2Cleared 510(K)
- K130942LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF2Cleared 510(K)
- K123996RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF2Cleared 510(K)
- K122058FLEXIPORT ECOCUFF2Cleared 510(K)
- K120125SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF2Cleared 510(K)
- K122259BLOOD PRESSURE MONITOR WITH STETHOSCOPE2Cleared 510(K)
- K120364UNIMED DISPOSABLE BLOOD PRESSURE CUFF2Cleared 510(K)
- K112544UNIMED BLOOD PRESSURE CUFF2Cleared 510(K)
- K103637ERKA. PERFECT-ANEROID2Cleared 510(K)
- K102825BLOOD PRESSURE CUFF2Cleared 510(K)
- K102792DISPOSABLE BLOOD PRESSURE CUF2Cleared 510(K)
- K102823DISPOSABLE BLOOD PRESSURE CUFF2Cleared 510(K)
- K101892HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-2Cleared 510(K)
- K101972SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS2Cleared 510(K)
- K092999NBP CUFF2Cleared 510(K)
- K092245ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-1002Cleared 510(K)
- K092604LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX2Cleared 510(K)
- K090014CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE2Cleared 510(K)
- K090664DEVON ACCUBP CUFF2Cleared 510(K)
- K082630VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES2Cleared 510(K)
- K080854DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC1002Cleared 510(K)
- K082542ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A2Cleared 510(K)
- K081951ANEROID SPHYGMOMANOMETER, MODEL KT-A012Cleared 510(K)
- K080189TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX2Cleared 510(K)
- K080366DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES2Cleared 510(K)
- K071244MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF2Cleared 510(K)
- K070060WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)2Cleared 510(K)
- K063863ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER2Cleared 510(K)
- K062238TYTAN BLOOD PRESSURE CUFF2Cleared 510(K)
- K061962SURGI-CUF REUSABLE, RS SERIES2Cleared 510(K)
- K060871AS101, BLOOD PRESSURE CUFF2Cleared 510(K)
- K053006ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II2Cleared 510(K)
- K051904ALL PURPOSE CUFF, MODEL 222APC2Cleared 510(K)
- K051539TRICOT BLOOD PRESSURE CUFF2Cleared 510(K)
- K051021ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A2Cleared 510(K)
- K043444MULTIPLE, MODEL KTJ-502Cleared 510(K)
- K043286ANEROID SPHYGMOMANOMETER, MODEL BK20022Cleared 510(K)
- K041689POLYURETHANE BLOOD PRESSURE CUFFS2Cleared 510(K)
- K032568BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 10301932Cleared 510(K)
- K040286ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS2Cleared 510(K)
- K031195CUF-COVER (TM)2Cleared 510(K)
- K031416CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF2Cleared 510(K)
- K023356KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR2Cleared 510(K)
- K022482SENSA-CUFF, MODELS INFANT, CHILD, ADULT2Cleared 510(K)
- K012553GSIBP BLOOD PRESSURE CUFF2Cleared 510(K)
- K012455WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM2Cleared 510(K)
- K012444ABN ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K012194BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-1102Cleared 510(K)
- K010686KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C2Cleared 510(K)
- K003415ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE2Cleared 510(K)
- K002955EMPIRE N BLOOD PRESSURE MANOMETERS2Cleared 510(K)
- K002954RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS2Cleared 510(K)
- K002360CLOUD CUFF2Cleared 510(K)
- K000512OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 10102Cleared 510(K)
- K994044CLEEN-ABLE2Cleared 510(K)
- K991545WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK2Cleared 510(K)
- K990412CUFF-ABLE PLUS2Cleared 510(K)
- K991525DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF2Cleared 510(K)
- K972899CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K974080CRITIKON SOFT BLOOD PRESSURE CUFF2Cleared 510(K)
- K972378SANAPHON N2Cleared 510(K)
- K972377RI-MEGA2Cleared 510(K)
- K972379PRECISA N2Cleared 510(K)
- K972301BIG BEN SQUARE, BIG BEN ROUND2Cleared 510(K)
- K963987CAMOUFLAGE CUFF SAVERS2Cleared 510(K)
- K964648PROTECT ALL BLOOD PRESSURE CUFF COVER2Cleared 510(K)
- K962655ANEROID AND MERCURIAL SPHYGMOMANOMETERS2Cleared 510(K)
- K954282ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG2Cleared 510(K)
- K951041BLOOD PRESSURE CUFF 32Cleared 510(K)
- K951040BLOOD PRESSURE CUFF 22Cleared 510(K)
- K951039BLOOD PRESSURE CUFF 12Cleared 510(K)
- K953952DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF2Cleared 510(K)
- K953466GENERICUFF2Cleared 510(K)
- K952825CUFF GUARD2Cleared 510(K)
- K950778MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER2Cleared 510(K)
- K945035OCL CONTOUR2Cleared 510(K)
- K942259TECHNICUFF2Cleared 510(K)
- K942488MEDCUFF2Cleared 510(K)
- K942777MINIMUS II; MINIMUS II COLOR; BABYPHON2Cleared 510(K)
- K936313CMS-90 BLOOD PRESSURE MEASUREMENT ASSISTANT2Cleared 510(K)
- K940493HAND ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K940214STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFF2Cleared 510(K)
- K925297RI-MED2Cleared 510(K)
- K934180SLIMLINE 30002Cleared 510(K)
- K925744TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF2Cleared 510(K)
- K931087CLEANCUFF(TM)2Cleared 510(K)
- K930604BALANCED(TM) NYLON BLADDER2Cleared 510(K)
- K925352CLEAN CUFF BLOOD PRESSURE CUFF LINER2Cleared 510(K)
- K921997CUFF-M2Cleared 510(K)
- K911213CUFFABLE2Cleared 510(K)
- K912638BLOOD PRESSURE CUFFS2Cleared 510(K)
- K912007BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF2Cleared 510(K)
- K910903INFLATE-A-CUFF #70142Cleared 510(K)
- K905147ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS2Cleared 510(K)
- K905101NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF2Cleared 510(K)
- K903379PYMAH PRE-GAGED BALANCED TEMPA-KUFF2Cleared 510(K)
- K901252HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS2Cleared 510(K)
- K902132CUFF, BLOOD PRESSURE2Cleared 510(K)
- K901506ANEROID SPHYGMOMANOMETER, DOCTOR TYPE2Cleared 510(K)
- K896986BLOOD PRESSURE CUFF2Cleared 510(K)
- K896788DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF2Cleared 510(K)
- K883977SURGI-CUF STERILE/NON-STERILE DISPOSABLE2Cleared 510(K)
- K884421PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT2Cleared 510(K)
- K881799BLOOD PRESSURE CUFF2Cleared 510(K)
- K882121C-FLO SUCTION TUBE2Cleared 510(K)
- K874233BLOOD PRESSURE SLEEVE W/TUBING2Cleared 510(K)
- K874939SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED2Cleared 510(K)
- K872144MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER2Cleared 510(K)
- K854813MEDNOVA BLOOD PRESSURE CUFF2Cleared 510(K)
- K854023NORELCO ELECTRONIC DIGITAL BP METER HC35012Cleared 510(K)
- K854752THE CALIFORNIA SPLINT2Cleared 510(K)
- K852193POROCOAT SCHATZKER II ACETABULUM2Cleared 510(K)
- K852964P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION2Cleared 510(K)
- K851565HOMEDICA CEMENTED ACETABULAR COMPONENT 62622Cleared 510(K)
- K844988ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.2Cleared 510(K)
- K831001UNICUFF-BLOOD PRESSURE CUFF2Cleared 510(K)
- K831393VASCULAB BLOOD PRESSURE CUFF2Cleared 510(K)
- K831479METAL-BACKED ACETABULAR CUP2Cleared 510(K)
- K823843FREEMAN ACETABULAR CUP2Cleared 510(K)
- K830097AUFRANC-TURNER ATS METAL BACKED ACETABU2Cleared 510(K)
- K821095SPHYGURITE2Cleared 510(K)
- K821232ONE HAND ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K820539RELIEVED REINFORCED CUP2Cleared 510(K)
- K813303CONPHAR, WALL ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K813302CONPHAR PALM ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K813323THIGH CUFF: X-LARGE CUFF2Cleared 510(K)
- K812946TRONZO HIP2Cleared 510(K)
- K811634NORELCO ANEROID BLOOD PRESSURE METER2Cleared 510(K)
- K810838NEONATAL BLOOD PRESSURE CUFF2Cleared 510(K)
- K810008ALP-KII2Cleared 510(K)
- K801568SHIELD DISPOSABLE BLOOD PRESSURE CUFF2Cleared 510(K)
- K801186CONPHAR DELUXE ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K801188CONPHAR DESK TOP MERCURY SPHYGMOMAN2Cleared 510(K)
- K801182CONPHAR WALL MODEL MERCURY SPHYGMOMAN.2Cleared 510(K)
- K801099UNICUF, BLOOD PRESSURE CUFF2Cleared 510(K)
- K800767MOD. MCI 17 MANUAL CUFF INFLATOR2Cleared 510(K)
- K800236ABCO MERCURIAL SPHYGMOMANOMETER2Cleared 510(K)
- K792355ANEROID SPHYMOMANOMETER2Cleared 510(K)
- K792108CONPHAR BLOOD PRESSURE CUFFS2Cleared 510(K)
- K791875PARKE-DAVIS TOTAL HIP PROSTHESIS2Cleared 510(K)
- K790810DISPOSA-CUF2Cleared 510(K)
- K781671BLOOD PRESSURE CUFF COVER2Cleared 510(K)
- K780715ANEROID TYPE BLOOD PRESSURE KIT2Cleared 510(K)
- K771501ANEROID SPHYGMOMETER2Cleared 510(K)
- K760655ANEROID SPHYGMOMANOMETER2Cleared 510(K)
- K760157SPHYGMOMANOMETER2Cleared 510(K)
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- 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
- Subpart F—Therapeutic DevicesCFR Sub-Part
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SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K120125
- 510(k) Type
- Traditional
- Applicant
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/3/2012
- Days to Decision
- 260 days
- Submission Type
- Summary