Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- FMFSyringe, Piston2Product Code
- FMGStopcock, I.V. Set2Product Code
- K242255Qitexio® 4-Way Stopcock (QIT014)2Cleared 510(K)
- K223499Three Way Stop Cock2Cleared 510(K)
- K223175lntravascular Administration Sets with Stopcock and Manifold2Cleared 510(K)
- K211204SafePort(TM) Manifold (or Stopcock)2Cleared 510(K)
- K210516Clicky Cross2Cleared 510(K)
- K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile2Cleared 510(K)
- K190489Elcam Stopcocks and Manifolds2Cleared 510(K)
- K172266Dynarex Three-Way Stopcock2Cleared 510(K)
- K141254ELCAM STOPCOCKS AND MANIFOLDS2Cleared 510(K)
- K123084DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD2Cleared 510(K)
- K130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO2Cleared 510(K)
- K082110DUAL SYRINGE HOLDER2Cleared 510(K)
- K082836ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES2Cleared 510(K)
- K082106ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)2Cleared 510(K)
- K080077CLAVE STOPCOCK2Cleared 510(K)
- K071400SMARTSITE STOPCOCK2Cleared 510(K)
- K070143JMS PLANECTA STOPCOCK2Cleared 510(K)
- K053405BACSTOP2Cleared 510(K)
- K061143ROBERTSITE STOPCOCK2Cleared 510(K)
- K060231CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK2Cleared 510(K)
- K052330TRU-SWAB STOCOCK2Cleared 510(K)
- K041779NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L2Cleared 510(K)
- K032393INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)2Cleared 510(K)
- K022895ELCAM STOPCOCKS AND MANIFOLDS2Cleared 510(K)
- K012157CHURCHILL MEDICAL SYSTEMS STOPCOCK2Cleared 510(K)
- K0102174 PORT, 4 WAY STOPCOCK2Cleared 510(K)
- K982368MANIFOLD WITH EXTENSION SET2Cleared 510(K)
- K974083CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS2Cleared 510(K)
- K964435PRIMARY IV SET2Cleared 510(K)
- K961982TRI-FLOW THREE WAY STOPCOCK2Cleared 510(K)
- K962581STOPCOCK MANIFOLD GANGS2Cleared 510(K)
- K954970STOPCOCK & LUER LOCK PLUG2Cleared 510(K)
- K955782MED-NET STOPCOCKS2Cleared 510(K)
- K954984MINIBORE STOPCOCK SET2Cleared 510(K)
- K953573ICU STOPCOK WITH EXTENSION TUBING2Cleared 510(K)
- K940070STOPCOCK INTRAVENOUS THERAPY2Cleared 510(K)
- K932512MULTI-PORT MANIFOLD2Cleared 510(K)
- K913560STOPCOCK2Cleared 510(K)
- K911415TRUMPET VALVE2Cleared 510(K)
- K902724ADVANCE DISPOSABLE STOPCOCK2Cleared 510(K)
- K891234TERUFUSION THREE WAY STOPCOCK2Cleared 510(K)
- K884463CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS2Cleared 510(K)
- K884435RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS2Cleared 510(K)
- K881805TU STOPCOCK2Cleared 510(K)
- K872067STERICAP ASSEMBLY AND REPLACEMENT TRAY2Cleared 510(K)
- K872066STERICAP STOPCOCK2Cleared 510(K)
- K864900VIGGO EXACTA PRESSURE MONITORING KIT2Cleared 510(K)
- K870261VIGGO EXACTA PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K870324#014460-120 3-WAY & #014461-120 4-WAY STOPCOCK2Cleared 510(K)
- K864440CHURCHILL 3-WAY STOPCOCK2Cleared 510(K)
- K862492EXEL THREE-WAY STOPCOCK2Cleared 510(K)
- K862691STOPCOCK2Cleared 510(K)
- K860889SAMPLE MANIFOLD HOLDER2Cleared 510(K)
- K854348CHURCHILL 3-WAY STOPCOCK SET2Cleared 510(K)
- K853275CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD2Cleared 510(K)
- K851986STOPCOCKS2Cleared 510(K)
- K850280VIGGO CONNECTA 3-WAY INFUSION STOPCOCK2Cleared 510(K)
- K842173DISPOSABLE STOPCOCKS2Cleared 510(K)
- K840394STOPCOCKS & EXTENSION TUBES2Cleared 510(K)
- K830198PEDIATRIC EXTEN. SET FOR SECOND-DRUG2Cleared 510(K)
- K823469TERUFUSION THREE-WAY STOPCOCK2Cleared 510(K)
- K823373BENZING RETROGRADE ADMIN. SET2Cleared 510(K)
- K823120EXACTA & CONNECTA STOPCOCKS W/EXTENSION2Cleared 510(K)
- K820165FLOW MED 3112Cleared 510(K)
- K812927ARTERIOGRAM TRAY2Cleared 510(K)
- K810375CENTURION STOPCOCK 3 WAY2Cleared 510(K)
- K802258STOPCOCK 2-WAY, 3-WAY & 4-WAY2Cleared 510(K)
- K8008621,3 & 4 WAY STERILE DIS. PLASTIC PKG.2Cleared 510(K)
- K800863TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS2Cleared 510(K)
- K800864STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE2Cleared 510(K)
- K800284THREE-WAY STOPCOCK EXTENSION SET 20-SL2Cleared 510(K)
- K792128STERILE EXTENSION TUBES INDIV. PKG.2Cleared 510(K)
- K792127PLAS. STCK. W/EXTENSION TUBE/STERILE2Cleared 510(K)
- K7921263&4 WAY PLASTIC STERILE STPCKS. PKG.2Cleared 510(K)
- K7921253&4 WAY PLASTIC STOPCOCKS, NONSTERILE2Cleared 510(K)
- K792124TANDEM ASSEMBLED 3&4 WAY STOPCOCKS2Cleared 510(K)
- K7821683-WAY STOPCOCK2Cleared 510(K)
- K782167DELTA FLOW2Cleared 510(K)
- K790010MANIFOLD, DISPOSABLE 3 VALVE2Cleared 510(K)
- K780662SUPPLEMENTAL TYGON PAC-MONITORING LINES2Cleared 510(K)
- K780596STOPCOCK2Cleared 510(K)
- K771911PLASTIC STOPCOCK W/ EXTENSION TUBE2Cleared 510(K)
- K770916TYGON PAC-MONITORING LINES & FLUID ADMIN2Cleared 510(K)
- K770708TYGON PAC-STOPCOCKS2Cleared 510(K)
- K770707TYGON PAC-MONITORING LINES & FLUID ADMIN2Cleared 510(K)
- K7606784-WAY STOPCOCK W/100 CM TUBING, LUER-LK2Cleared 510(K)
- K7606794-WAY STOPCOCK W/7CM TUBING,2Cleared 510(K)
- K7606674-WAY STOPCOCK W/10 CM EXTEN. TUBING2Cleared 510(K)
- K7606664-WAY STOPCOCK W/LUER-LOCK FITTING2Cleared 510(K)
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- FRPHolder, Infant Position1Product Code
- FRRChamber, Reverse Isolation, Patient Care2Product Code
- FSALift, Patient, Non-Ac-Powered1Product Code
- FSDBinder, Abdominal1Product Code
- HEFBinder, Breast1Product Code
- HFSShield, Nipple1Product Code
- IKYMattress, Flotation Therapy, Non-Powered1Product Code
- KMKDevice, Intravascular Catheter Securement1Product Code
- KMOBinder, Elastic1Product Code
- KPEContainer, I.V.2Product Code
- KYPSnake Bite Suction Kit1Product Code
- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- 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
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
- Page Type
- Cleared 510(K)
- 510(k) Number
- K082836
- 510(k) Type
- Special
- Applicant
- Icu Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/25/2009
- Days to Decision
- 152 days
- Submission Type
- Summary