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
- 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
- K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F1Cleared 510(K)
- K981860A P HARNESS1Cleared 510(K)
- K963365MULTI-PURPOSE MEDICAL TUBE HOLDER1Cleared 510(K)
- K941098SECURE-SITE1Cleared 510(K)
- K943147STATLOCK CV1Cleared 510(K)
- K943047IV START KITS1Cleared 510(K)
- K941940IMMOBILE STERILE AND IMMOBILE A/C STERILE1Cleared 510(K)
- K941850IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE1Cleared 510(K)
- K935389CONMED VENI-GARD I.V. DRESSING1Cleared 510(K)
- K935252K-LOK CATHETER SECUREMENT DEVICE MODIFICATION1Cleared 510(K)
- K940127CENTERMARK SECURING WINGS1Cleared 510(K)
- K932757SECURODRIP (TM) I.V. ARMBOARD1Cleared 510(K)
- K925992DUODERM TRANSPARENT HYDROCOLLOID DRESSING1Cleared 510(K)
- K930663IV COMFORT PAD1Cleared 510(K)
- K922103IAB ANCHOR1Cleared 510(K)
- K930225K-LOK CATHETER SECUREMENT DEVICE1Cleared 510(K)
- K930197KWIK BOARD1Cleared 510(K)
- K924180I.V. PRO1Cleared 510(K)
- K924369ILS(TM) - INVASIVE LINE SEPARATOR1Cleared 510(K)
- K924249DERMASSIST TRANSPARENT SITE DRESSING1Cleared 510(K)
- K925502TRACE MODEL# 840, 841,842 & 845 ARM BOARD1Cleared 510(K)
- K924567FOLEY CATHETER TUBE HOLDER NO. 1011Cleared 510(K)
- K924566RESTRAINT, PROTECTIVE N0. 1031Cleared 510(K)
- K924568TUBE, LEAD, AND CORD HOLDER NO. 1021Cleared 510(K)
- K915495DESERET POSITIONAL SUTURE WING1Cleared 510(K)
- K912660SECURODRIP1Cleared 510(K)
- K912942IV HOUSE1Cleared 510(K)
- K912211INTRAVASCULAR CATHETER SECURMENT DEVICE1Cleared 510(K)
- K911070PICC-FIX1Cleared 510(K)
- K910880COMFOR-BOARD1Cleared 510(K)
- K905735GENNY DENNY IV SHIELD1Cleared 510(K)
- K900134BABY BOARDS IV SUPPORT ASSEMBLY1Cleared 510(K)
- K896046VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE1Cleared 510(K)
- K895993VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE1Cleared 510(K)
- K895431JOHNSON & JOHNSON TUBE SECUREMENT DEVICE1Cleared 510(K)
- K894586DALE I.V. IDENTIFIER; PRODUCT #11251Cleared 510(K)
- K873311DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)2201Cleared 510(K)
- K870770TIMLEINE(TM) VENIPUNCTURE SYSTEM1Cleared 510(K)
- K864190E-Z HOLD - #40601Cleared 510(K)
- K860706IV BAND (INTRAVENOUS CATHETER ASSESORY)1Cleared 510(K)
- K860071HOLD-IT FRAMED ADHESIVE FILM1Cleared 510(K)
- K854040I.V. DRESSING1Cleared 510(K)
- K853418SAFTI-BRACELET1Cleared 510(K)
- K850503SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS1Cleared 510(K)
- K843882TRENDS LANCET1Cleared 510(K)
- K842999VENI-SHIELD1Cleared 510(K)
- K841487INTRAVASCULAR CATHETER SECUREMENT DEV1Cleared 510(K)
- K840683FPP IV SECURE1Cleared 510(K)
- K832300I.V. FILTER HOLDER1Cleared 510(K)
- K830300FREHAN INC. I.V. FILTER HOLDER1Cleared 510(K)
- K822732LINEGUARD CATHETER SHIELD MODEL 1001Cleared 510(K)
- K821957CATH-LOK1Cleared 510(K)
- K821796EZ-FIX I.V. CATHETER HOLDER1Cleared 510(K)
- K821317UNIVERSAL I.V. HOLDER1Cleared 510(K)
- K820759VEIN-SHIELD1Cleared 510(K)
- K812080AEGIS I.V. STRIPS1Cleared 510(K)
- K810579ADHESIVE I.V. CATHETER DRESSING1Cleared 510(K)
- K800726EYEWI ANKORS1Cleared 510(K)
- K800024I.V. TAPE DOWN HOLDER1Cleared 510(K)
- K792049I.V. STRIP1Cleared 510(K)
- K781800GRIP, HOSPITAL UTILITY1Cleared 510(K)
- K770119I.V. LOK TM1Cleared 510(K)
- 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
IAB ANCHOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K922103
- 510(k) Type
- Traditional
- Applicant
- DATASCOPE CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/3/1993
- Days to Decision
- 454 days
- Submission Type
- Statement