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
- DQFActuator, Syringe, Injector Type2Product Code
- DQIWithdrawal/Infusion Pump2Product Code
- DXTInjector And Syringe, Angiographic2Product Code
- K242143Angiography Injector2Cleared 510(K)
- K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)2Cleared 510(K)
- K241109Single-use Sterile High-pressure Angiographic Syringes and Accessories2Cleared 510(K)
- K230668Disposable High-pressure Extension Lines2Cleared 510(K)
- K232388High Pressure Tubing2Cleared 510(K)
- K211564Sterile High-pressure Angiographic Syringes for Single-use2Cleared 510(K)
- K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System2Cleared 510(K)
- K201395Sterile High-pressure Angiographic Syringes for single-use2Cleared 510(K)
- K192657Sterile High-pressure Angiographic Syringes for Single-use2Cleared 510(K)
- K192370MEDRAD Stellant FLEX CT Injection System with Certegra Workstation2Cleared 510(K)
- K193028MEDRAD Mark 7 Arterion Injection System2Cleared 510(K)
- K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System2Cleared 510(K)
- K191060ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit2Cleared 510(K)
- K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System2Cleared 510(K)
- K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT2Cleared 510(K)
- K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit2Cleared 510(K)
- K181936DyeVert PLUS EZ Contrast Reduction System2Cleared 510(K)
- K182289Sterile High-pressure Angiographic Syringes for Single-use2Cleared 510(K)
- K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT2Cleared 510(K)
- K172694Sterile Disposable Syringes2Cleared 510(K)
- K171646ACISTCVi® Contrast Delivery System2Cleared 510(K)
- K173450PRESS DUO elite, PRESS DUO elite AG2Cleared 510(K)
- K170279Disposable High Pressure Syringe2Cleared 510(K)
- K170014High Pressure Tubing2Cleared 510(K)
- K170025Angiography Syringe2Cleared 510(K)
- K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip2Cleared 510(K)
- K171698Smart Syringe2Cleared 510(K)
- K163084Merit Coronary Control Syringe2Cleared 510(K)
- K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System2Cleared 510(K)
- K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System2Cleared 510(K)
- K162088Ecomed Disposable Angiographic Syringes2Cleared 510(K)
- K152906Disposable High Pressure Injector Syringe2Cleared 510(K)
- K160190Sunmed Control Syringes2Cleared 510(K)
- K161471MR Syringe Dual Pack for Solaris Injectors2Cleared 510(K)
- K161505DyeVert NG Contrast Modulation System2Cleared 510(K)
- K160107DiamondTOUCH Inflation Device and Fluid Dispensing Syringe2Cleared 510(K)
- K152978DeRoyal Angiography Kits2Cleared 510(K)
- K153141DyeVert Contrast Modulation System2Cleared 510(K)
- K151960Sterile High-pressure Angiographic Syringes for Single-use2Cleared 510(K)
- K150902330psi Extension Y-Line with Dual Check Valve2Cleared 510(K)
- K151300AVERT Contrast Modulation System2Cleared 510(K)
- K151746Dyevert Contrast Modulation System2Cleared 510(K)
- K152218AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System2Cleared 510(K)
- K143538MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit2Cleared 510(K)
- K142745125mL CT Syringe2Cleared 510(K)
- K150485AVERT Contrast Modulation System2Cleared 510(K)
- K142081CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES2Cleared 510(K)
- K140469MR SYRINGE DUAL PACK2Cleared 510(K)
- K133189DUAL SHOT ALPHA 72Cleared 510(K)
- K140425CONTRAST MODULATION SYSTEM2Cleared 510(K)
- K133600COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR2Cleared 510(K)
- K132928MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE2Cleared 510(K)
- K131478CONTRAST CONSERVATION SYSTEM2Cleared 510(K)
- K120892DISPOSABLE 330PSI EXTENSION LINES2Cleared 510(K)
- K113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE2Cleared 510(K)
- K113198NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML2Cleared 510(K)
- K112086MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE2Cleared 510(K)
- K093830MEDLINE ANGIOGRAPHIC CONTROL SYRINGE2Cleared 510(K)
- K092896REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS2Cleared 510(K)
- K090487DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-51502Cleared 510(K)
- K090621FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 1002Cleared 510(K)
- K082439DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT2Cleared 510(K)
- K083523MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE2Cleared 510(K)
- K082212SYRINGE WITH HANDI-FIL2Cleared 510(K)
- K082905MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC2Cleared 510(K)
- K073592OPTISTAR ELITE INJECTION SYSTEM2Cleared 510(K)
- K072696ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,3012Cleared 510(K)
- K072886MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T2Cleared 510(K)
- K071691DUAL SHOT ALPHA2Cleared 510(K)
- K070798ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS2Cleared 510(K)
- K061976CKIS-004A INJECTOR SYNCHRONIZATION OPTION2Cleared 510(K)
- K062168CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA2Cleared 510(K)
- K052744C2000 AUTOMATED MANIFOLD KIT2Cleared 510(K)
- K051799DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS2Cleared 510(K)
- K052633DUAL SHOT - CONTRAST DELIVERY SYSTEM2Cleared 510(K)
- K050456MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM2Cleared 510(K)
- K042784MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM2Cleared 510(K)
- K042744OPTIV ANTAGE DH POWER INJECTION SYSTEM2Cleared 510(K)
- K040298ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS2Cleared 510(K)
- K033881MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE2Cleared 510(K)
- K032920THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-60032Cleared 510(K)
- K033247MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM2Cleared 510(K)
- K031483MEDRAD MANUAL SYRINGE LOADER2Cleared 510(K)
- K031339OPTIBOLUS2Cleared 510(K)
- K020892ACIST GENTOO CONTRAST INJECTION SYSTEM2Cleared 510(K)
- K023183MEDRAD STELLANT CT INJECTOR SYSTEM2Cleared 510(K)
- K022116ELPH INJECTION SYSTEM2Cleared 510(K)
- K020333ATRION MEDICAL QL FLUID DISPENSING SYRINGE2Cleared 510(K)
- K013815MEDRAD QWIK-FIT SYRINGE2Cleared 510(K)
- K012950MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM2Cleared 510(K)
- K011811MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE2Cleared 510(K)
- K011991MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR2Cleared 510(K)
- K010390ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS2Cleared 510(K)
- K001663FRONT-LOAD POLYPROPYLENE SYRINGE2Cleared 510(K)
- K991103MODIFICATION TO ACIST CL 100H2Cleared 510(K)
- K984231ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B2Cleared 510(K)
- K000013ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-20002Cleared 510(K)
- K9838263S INJECTOR-CT CONTRAST DELIVERY SYSTEM2Cleared 510(K)
- K993774ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH2Cleared 510(K)
- K984088OPTISTAR MR INJECTOR SYSTEM2Cleared 510(K)
- K993728MEDRAD ENVISION CT INJECTOR SYSTEM2Cleared 510(K)
- K991557MEDRAD VISTRON CT INJECTOR SYSTEM2Cleared 510(K)
- K984418UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET2Cleared 510(K)
- K982814MEDRAD VISTRON CT INJECTOR SYSTEM2Cleared 510(K)
- K973334OZ POWER SYRINGE2Cleared 510(K)
- K963982ACIST ANGIOGRAPHIC INJECTOR2Cleared 510(K)
- K973230MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)2Cleared 510(K)
- K971712COEUR 130 ML ANGIOGRAPHIC SYRINGE2Cleared 510(K)
- K963071ANGIOMAT ILLUMENA2Cleared 510(K)
- K964642MEDRAD DISPOSABLE SYRINGES2Cleared 510(K)
- K962141VOLUME CONTROL SYRINGE MODEL VCD-SYR-102Cleared 510(K)
- K955685RNS STERILE, DISPOSABLE CT BIOPSY TRAY2Cleared 510(K)
- K960674CONTRAST INJECTION LINES2Cleared 510(K)
- K960965FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-02112Cleared 510(K)
- K960430CONTROL SYRINGE2Cleared 510(K)
- K955684RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY2Cleared 510(K)
- K955381B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT2Cleared 510(K)
- K935668MEDRAD SPECTRIS MR INJECTOR2Cleared 510(K)
- K951802SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT2Cleared 510(K)
- K934086MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE2Cleared 510(K)
- K942381LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING2Cleared 510(K)
- K944875ANGIOMAT 3000, 6000, CT INJECTOR2Cleared 510(K)
- K933846ANGIOGRAPHY SYRINGE KITS2Cleared 510(K)
- K933908MEDRAD CT CUSTOM CONVENIENCE KIT2Cleared 510(K)
- K932083XDCS-1002Cleared 510(K)
- K924116MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD2Cleared 510(K)
- K913624MEDRAD MCT-PLUS INJECTOR2Cleared 510(K)
- K920135MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE2Cleared 510(K)
- K912944CT 8000 DIGITAL INJECTION SYSTEM2Cleared 510(K)
- K910594TRAC-WRIGHT SYSTEM, MODEL TW22Cleared 510(K)
- K905819MEDRAD VARIBLE INFUSION INJECTOR2Cleared 510(K)
- K911549INJECTOR FILL TUBE2Cleared 510(K)
- K910873BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP2Cleared 510(K)
- K904994CLOSED SYSTEM FLUSH SET2Cleared 510(K)
- K902377ANGEFLATOR(TM)2Cleared 510(K)
- K904212HIGH-PRESSURE CONNECTOR TUBE2Cleared 510(K)
- K902475CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS2Cleared 510(K)
- K903390MEDRAD MARK V-PLUS INJECTOR2Cleared 510(K)
- K902221MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE2Cleared 510(K)
- K901382ISOFLO(TM) HIGH PRESSURE INJECTION LINES2Cleared 510(K)
- K900034ANGIO-MAX2Cleared 510(K)
- K896415USCI PRESTO DISPOSABLE INFLATION DEVICE2Cleared 510(K)
- K895318B-D ANGIOGRAPHIC CONTROL SYRINGE2Cleared 510(K)
- K890292PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE2Cleared 510(K)
- K890208HIGH PRESSURE CONNECTING SETS2Cleared 510(K)
- K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)2Cleared 510(K)
- K890898MODEL 611101 CONTRAST INJECTION DEVICE2Cleared 510(K)
- K883769EXCEL INFLATE-AID2Cleared 510(K)
- K883452ACS INDEFLATOR P/T 202Cleared 510(K)
- K882329L-F COILED EXTENSION TUBING2Cleared 510(K)
- K881521MODIFIED SERVO SYRINGE2Cleared 510(K)
- K880877CONTRAST INJECTION DEVICE2Cleared 510(K)
- K880987INJECTOR HANDLE WITH SYRINGE2Cleared 510(K)
- K880493MEDRAD MICROPROCESSOR CT INJECTION SYSTEM2Cleared 510(K)
- K880310ANGIO DRAPE PACK ACP-010FM2Cleared 510(K)
- K875324MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES2Cleared 510(K)
- K873410DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE2Cleared 510(K)
- K875196DISPOSABLE CORONARY CONTROL SYRINGE 12CC2Cleared 510(K)
- K873955NAMIC ANGIOGRAPHIC SYRINGE2Cleared 510(K)
- K873173MEDRAD MRI INJECTION SYSTEM2Cleared 510(K)
- K873597TUBING, POLYETHYLENE2Cleared 510(K)
- K872981ACS INDEFLATOR PLUS (MODIFICATION #2)2Cleared 510(K)
- K873687ANGIOMAT CT INJECTOR2Cleared 510(K)
- K872472SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE2Cleared 510(K)
- K863596CHIN-FOGARTY INFLATION DEVICE2Cleared 510(K)
- K863537CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY2Cleared 510(K)
- K863037USCI (R) DISPOSABLE INFLATION DEVICE2Cleared 510(K)
- K862547MECHANICAL INFLATION DEVICE2Cleared 510(K)
- K860204ANGIOMAT 60002Cleared 510(K)
- K860842ANGIOJECT2Cleared 510(K)
- K850861ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE2Cleared 510(K)
- K854310ACS INDEFLATOR (MODIFICATION)2Cleared 510(K)
- K841092HIGH PRESSURE FLEX. CONNECTING TUBING2Cleared 510(K)
- K851402LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE2Cleared 510(K)
- K844045ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT2Cleared 510(K)
- K841493MODEL 1000 APC-ANGIOPLASTY PRESSURE2Cleared 510(K)
- K840281ANGIOGRAPHIC DRAPE PACKS2Cleared 510(K)
- K833645CONTRAST MEDIA INJECT. SET CMS2Cleared 510(K)
- K834107ANGIOPLASTY INFLATION DEVICE & CARTR2Cleared 510(K)
- K833138DIGITAL INJECTOR SYS2Cleared 510(K)
- K830754BLOOD PRESSURE MONITORING KITS,WALRUS2Cleared 510(K)
- K830609INFLATION DEVICE2Cleared 510(K)
- K823920COEURLOCK STERILE DISPOS. ANGIOGRAPHIC2Cleared 510(K)
- K823340CLEAR VINYL MONITORING CONNECTOR2Cleared 510(K)
- K823238INJECTION FILL TUBE2Cleared 510(K)
- K823253VERTEX MONITORING CATHETER2Cleared 510(K)
- K823254REUSABLE METAL STOPCOCK2Cleared 510(K)
- K823256ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE2Cleared 510(K)
- K823192TUOHY-BORST ADAPTER W/SIDE ARM2Cleared 510(K)
- K823191DISPOSABLE PLASTIC STOPCOCK2Cleared 510(K)
- K823190BACKSTOP VALVE W/SIDE ARM2Cleared 510(K)
- K823356READY-BOX BODY-TEMP MEDIA WARMER MALLIN-2Cleared 510(K)
- K822536MARK V2Cleared 510(K)
- K821401MALLINCKRODT DIAG. MEDIA WARMER2Cleared 510(K)
- K800823QUICK FILL2Cleared 510(K)
- K800613ANGIOPLASTY INJECTOR2Cleared 510(K)
- K791793USCI PRESSURE GAUGE2Cleared 510(K)
- K791782USCI BALLOON DILATATION INFLATION DEV.2Cleared 510(K)
- K790835DYNAJECT2Cleared 510(K)
- K781334DISPOSABLE SYRINGE FILL TUBE2Cleared 510(K)
- IZQInjector, Contrast Medium, Automatic2Product Code
- NKPInjector, Contrast Medium, Automatic, Reprocessed2Product Code
- NKTInjector And Syringe, Angiographic, Reprocessed2Product Code
- 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
- 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
OPTIBOLUS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K031339
- 510(k) Type
- Special
- Applicant
- MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/11/2003
- Days to Decision
- 74 days
- Submission Type
- Summary