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
- K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)2Cleared 510(K)
- K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)2Cleared 510(K)
- K221707SafeSept® Transseptal Guidewire (SS-140)2Cleared 510(K)
- K212625PathBuilder Transseptal Needle2Cleared 510(K)
- K210328SafeSept Blunt Needle2Cleared 510(K)
- K172950TSN Transseptal Needle2Cleared 510(K)
- K172934Needle Free Transseptal Cannula2Cleared 510(K)
- K172893SafeSept Needle Free Transseptal Guidewire2Cleared 510(K)
- K170671SafeSept Transseptal Guidewire2Cleared 510(K)
- K132943INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE2Cleared 510(K)
- K130843SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE2Cleared 510(K)
- K122587BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G4072082Cleared 510(K)
- K122832MOBICATH TRANSSEPTAL NEEDLE2Cleared 510(K)
- K111644MOBICATH TRANSSEPTAL NEEDLE2Cleared 510(K)
- K081986SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE2Cleared 510(K)
- K072278BRK TRANSSEPTAL NEEDLE2Cleared 510(K)
- K061070HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR2Cleared 510(K)
- K022117MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-52Cleared 510(K)
- K022257VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX2Cleared 510(K)
- K011727TRANSSEPTAL NEEDLE/TROCAR2Cleared 510(K)
- K011373INSTRUMENT DAMPING PORT2Cleared 510(K)
- K011349INTERCOSTAL LOCKABLE-DIRECTABLE PORT2Cleared 510(K)
- K974745MANAN GWI GUIDE WIRE INTRODUCER2Cleared 510(K)
- K974742MANAN POTTS-COURNAND NEEDLE2Cleared 510(K)
- K974743MANAN2Cleared 510(K)
- K964302HEARTPORT THORACIC TROCAR2Cleared 510(K)
- K965051HEARTPORT NEEDLE TROCAR2Cleared 510(K)
- K951448GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE2Cleared 510(K)
- K936247MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES2Cleared 510(K)
- K940036ENDOSURG DISPOSABLE SECONDARY TROCAR2Cleared 510(K)
- K924338ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE2Cleared 510(K)
- K913267R-GROUP INTL. ONE WALL PUNCTURE NEEDLE2Cleared 510(K)
- K914985DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION2Cleared 510(K)
- K911483LAPAROSCOPIC TROCAR2Cleared 510(K)
- K911462SURGICAL TROCAR2Cleared 510(K)
- K900664DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES2Cleared 510(K)
- K895455SELDINGER PERCUTANEOUS 2 PC NEEDLES2Cleared 510(K)
- K895454SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)2Cleared 510(K)
- K893707AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT2Cleared 510(K)
- K890209DISPOSABLE ANGIOGRAPHY NEEDLES2Cleared 510(K)
- K871377NAMIC COURNAND STYLE INTRODUCER NEEDLE2Cleared 510(K)
- K871382NAMIC ONE PART INTRODUCER NEEDLE2Cleared 510(K)
- K871378NAMIC SELDINGER INTRODUCER NEEDLE2Cleared 510(K)
- K854293MEDSURG POTT-COURNAND NEEDLE2Cleared 510(K)
- K854294MEDSURG SELDINGER NEEDLE2Cleared 510(K)
- K853132EMERSON TRO/CATH TROCAR CATHETERS2Cleared 510(K)
- K840529STEIGER TUNNELING INSTRUMENT 2852Cleared 510(K)
- K811964VISITEC NEEDLE RANGE (CARDIOVASCULAR)2Cleared 510(K)
- K781221DILUTION KIT, THERMAL, COLD PAC2Cleared 510(K)
- K772369NEEDLES USED IN ANGIOGRAPHIC PROCED.2Cleared 510(K)
- K771261ADVANSET2Cleared 510(K)
- 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
- 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
- NPGCatheter, Infusion, Syringe2Product 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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HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
- Page Type
- Cleared 510(K)
- 510(k) Number
- K061070
- 510(k) Type
- Traditional
- Applicant
- Hansen Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/13/2006
- Days to Decision
- 179 days
- Submission Type
- Summary