Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- DSTClip, Vena-Cava2Product Code
- DSWBag, Polymeric Mesh, Pacemaker1Product Code
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2Product Code
- DSZPacemaker Battery3Product Code
- DTATester, Pacemaker Electrode Function2Product Code
- DTBPermanent Pacemaker Electrode3Product Code
- DTCAnalyzer, Pacemaker Generator Function2Product Code
- DTDPacemaker Lead Adaptor2Product Code
- DTEPulse-Generator, Pacemaker, External2Product Code
- DTFTools, Pacemaker Service1Product Code
- DTGMagnet, Test, Pacemaker1Product Code
- DTISizer, Heart-Valve, Prosthesis1Product Code
- DTJHolder, Heart-Valve, Prosthesis1Product Code
- DTKFilter, Intravascular, Cardiovascular2Product Code
- DSPSystem, Balloon, Intra-Aortic And Control2Product Code
- DSRStimulator, Carotid Sinus Nerve3Product Code
- DSSClip, Vascular2Product Code
- DXYImplantable Pacemaker Pulse-Generator3Product Code
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2Product Code
- DYEReplacement Heart-Valve3Product Code
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter2Product Code
- KFJMaterials, Repair Or Replacement, Pacemaker3Product Code
- KRDDevice, Vascular, For Promoting Embolization2Product Code
- KREAnalyzer, Pacemaker Generator Function, Indirect2Product Code
- KRFCharger, Pacemaker1Product Code
- KRGProgrammer, Pacemaker3Product Code
- KRHRing, Annuloplasty2Product Code
- LDFElectrode, Pacemaker, Temporary2Product Code
- K242863Bioptimal Bipolar Pacing Catheter2Cleared 510(K)
- K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)2Cleared 510(K)
- K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,2Cleared 510(K)
- K241199Rotatable Connector (5944RL)2Cleared 510(K)
- K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)2Cleared 510(K)
- K232261TME Temporary Myocardial Electrode2Cleared 510(K)
- K190716Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead2Cleared 510(K)
- K173923Temporary Cardiac Pacing Wire2Cleared 510(K)
- K171253Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead2Cleared 510(K)
- K161873Pacel Flow Directed Pacing Catheter2Cleared 510(K)
- K160260Tempo Temporary Pacing Lead2Cleared 510(K)
- K161249Streamline 6495 Bipolar Temporary Myocardial Pacing Lead2Cleared 510(K)
- K152784Pacel Bipolar Pacing Catheters2Cleared 510(K)
- K152633Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe2Cleared 510(K)
- K140972UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING2Cleared 510(K)
- K072770TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)2Cleared 510(K)
- K042190MODEL 6416 TEMPORARY PACING LEAD SYSTEM2Cleared 510(K)
- K040812DETECT SURGICAL PACING AND MAPPING TOOL2Cleared 510(K)
- K033858TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE2Cleared 510(K)
- K032613TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE2Cleared 510(K)
- K023174DISPOSABLE TEMPORARY PACING WIRE2Cleared 510(K)
- K030556STEELEX ELECTRODE SET2Cleared 510(K)
- K011660WECK CARDIAC PACING WIRES2Cleared 510(K)
- K012454MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD2Cleared 510(K)
- K012458MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD2Cleared 510(K)
- K012460MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD2Cleared 510(K)
- K012459MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE2Cleared 510(K)
- K012452MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD2Cleared 510(K)
- K010099ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER2Cleared 510(K)
- K002603ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER2Cleared 510(K)
- K002481ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-32Cleared 510(K)
- K002687ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-32Cleared 510(K)
- K973360MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD2Cleared 510(K)
- K980503TEMPORARY CARDIAC PACING WIRE2Cleared 510(K)
- K971775INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV6102Cleared 510(K)
- K955829SAFPACE SYSTEM2Cleared 510(K)
- K962833HARMAC TEMPORARY PACING CATHETER WITH BALLOON2Cleared 510(K)
- K963073HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET2Cleared 510(K)
- K971165INTRODUCER SHEATH AND DILATOR2Cleared 510(K)
- K963898MODEL 6495 BIPOLAR TEMPORARY PACING LEAD2Cleared 510(K)
- K961520UNIPOLAR IPG GROUND CABLE, MODEL 54732Cleared 510(K)
- K960479ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER2Cleared 510(K)
- K955712USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING2Cleared 510(K)
- K962467RV PACING LEAD2Cleared 510(K)
- K955722FLEXON TEMPORARY CARDIAC PACER LEAD2Cleared 510(K)
- K954809UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 64942Cleared 510(K)
- K934785MULTIPACE2Cleared 510(K)
- K944966UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 64922Cleared 510(K)
- K944957TEMPORARY MYOCARDIAL PACING LEAD, MODEL 65002Cleared 510(K)
- K944956UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 64912Cleared 510(K)
- K934787SILICORE SEMI-FLOATER2Cleared 510(K)
- K930069BIPOLAR BALLOON PACING CATHETER BY J-LLOYD2Cleared 510(K)
- K924388ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD2Cleared 510(K)
- K924390ANGEMED 5000 LEAD ADAPTER2Cleared 510(K)
- K922269UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 64932Cleared 510(K)
- K922268UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 64912Cleared 510(K)
- K922182UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 64922Cleared 510(K)
- K923407MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES2Cleared 510(K)
- K914185PACEL(TM) FLOW DIRECTED PACING CATHETER2Cleared 510(K)
- K913521XEMEX TEMPORARY PACING CATHETER A MODIFIED2Cleared 510(K)
- K904868XEMEX TEMPORARY PACING CATHETER A2Cleared 510(K)
- K902342UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #64912Cleared 510(K)
- K900982E-CLIP2Cleared 510(K)
- K895789UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 64902Cleared 510(K)
- K890988MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE2Cleared 510(K)
- K890794DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER2Cleared 510(K)
- K884866TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-12Cleared 510(K)
- K882330BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER2Cleared 510(K)
- K882045HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK2Cleared 510(K)
- K881356EXTERNAL PACEMAKER WIRE DRESSING CHANGE2Cleared 510(K)
- K875059DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE2Cleared 510(K)
- K874310WIRE DRESSING2Cleared 510(K)
- K872972TEMPORARY PACEMAKER ELECTRODE2Cleared 510(K)
- K873728DEKNATEL TEMPORARY CARDIAC PACING WIRE2Cleared 510(K)
- K873474SUTURELESS TEMPORARY EPICARDIAL PACING LEAD2Cleared 510(K)
- K873716ADULT WALKING HEEL PRODUCT NO. 4183-1302Cleared 510(K)
- K862970TEMPORARY MYOCARDIAL PACING LEAD, MODEL 65002Cleared 510(K)
- K864507V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP55402Cleared 510(K)
- K861403TB SERIES BIPOLAR PACING LEADS2Cleared 510(K)
- K861409SYNCARE TEMPORARY CARDIAC PACING WIRE2Cleared 510(K)
- K855139FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT2Cleared 510(K)
- K853818MEDTRONIC MODEL 64052Cleared 510(K)
- K852797HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE2Cleared 510(K)
- K852513115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD2Cleared 510(K)
- K851913CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA2Cleared 510(K)
- K851845NUMED TEMP. STYLET PACING PAROBE 13186942Cleared 510(K)
- K851246NUMED BALLOON PACING CATHETER2Cleared 510(K)
- K850622OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR2Cleared 510(K)
- K850324ELECATH OPEN TIP BIPOLAR PACING CATHETER2Cleared 510(K)
- K843290NUMED BALLOON PACING CATHETER2Cleared 510(K)
- K844003ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH2Cleared 510(K)
- K841802ELECTRODE CATHETER, ORTHOGONAL TYPE2Cleared 510(K)
- K843141CRITIKON HEPARIN-COATED CARDIOVASCULAR2Cleared 510(K)
- K834416LUMELEC ELECTRODE CATHETER2Cleared 510(K)
- K840109ELECATH HEPARIN COATED TEMP. PACING2Cleared 510(K)
- K831804MULTIPOLAR TEMPORARY CARDIAC2Cleared 510(K)
- K831695TEMP. CARDIAC PACING WIRE TME 60/61/652Cleared 510(K)
- K832850ELECATH PACEWEDGE DUAL PRESS. BIPOLAR2Cleared 510(K)
- K832561EPCOR MULTIELECTRODE TEMP. PERVENOUS2Cleared 510(K)
- K831645TEMP. BIPOLAR EPICARDIAL LEAD2Cleared 510(K)
- K830772TEMP. PACING LEAD, BIPOLAR #TH60, 90/1102Cleared 510(K)
- K830094USCI TEMP. ATRIO-VENTRICULAR ELECTRODE2Cleared 510(K)
- K822003BALLOON TEMP. PACING CATHETER2Cleared 510(K)
- K822002BIPOLAR TEMP. PACING CATHETER W/STYLETET2Cleared 510(K)
- K821518MYO/CLIP2Cleared 510(K)
- K821333ATRIAL J TEMPORARY PACING ELECTRODESS2Cleared 510(K)
- K820232TRANSTHORACIC TEMP. PACEMAKER #100TPE2Cleared 510(K)
- K820003CARDIOVASCULAR TEMP. PACEMAKER ELEC2Cleared 510(K)
- K813521TRANSLUMINAL BIPOLAR PACING PROBE2Cleared 510(K)
- K813138ETHICON* TEMP. CARDIAC PACING WIRE2Cleared 510(K)
- K812725MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD2Cleared 510(K)
- K812781TEMPORARY PERVENOUS J-ATRIAL LEAD2Cleared 510(K)
- K812517CARDIAC PACING ELECTRODES2Cleared 510(K)
- K812307USCI TRANSTHORACIC TEMP. PACING ELECTROD2Cleared 510(K)
- K811318TEMPORARY ENDOCARDIAL TRIPOLAR LD. #68802Cleared 510(K)
- K803086MYOWIRE-ATEMPORARY CARDIAC PACING WIRE2Cleared 510(K)
- K810657TEMPTRON #'S 6804/68052Cleared 510(K)
- K810643UNIVERSAL PACING ELECTRODE KIT2Cleared 510(K)
- K810642ATRIAL-VENTRICULAR PACING ELECTRODE KIT2Cleared 510(K)
- K810312ELECATH DUAL MODE TRANSTHORACIC PACING2Cleared 510(K)
- K810041CORDIS TEMPORATY CURVED ATRIAL LEAD2Cleared 510(K)
- K803058SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.2Cleared 510(K)
- K801799ATRIAL/VENTRICULAR SEQENTIAL #080-200002Cleared 510(K)
- K802259TRANSVENOUS PACEMAKER ELECTRODE KIT2Cleared 510(K)
- K801800UNIVERSAL TEMP. PACING ELECT. #080-100002Cleared 510(K)
- K800298USCI BIPOLAR BALLON PACING ELECTRODE2Cleared 510(K)
- K791183SWAN-GANZ FLOW-DIRECTED CATHETER2Cleared 510(K)
- K781002TEMPORARY CARDIAC PACING WIRE2Cleared 510(K)
- MABMarker, Cardiopulmonary Bypass (Vein Marker)2Product Code
- MALGraft, Vascular, Synthetic/Biologic Composite2Product Code
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries2Product Code
- MOPRotator, Prosthetic Heart Valve1Product Code
- MZYGraft, Vascular, Stainless Steel Tunneler2Product Code
- NHWElectrode, Pacing And Cardioversion, Temporary, Epicardial2Product Code
- NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed3Product Code
- OKRVentricular Bypass (Assist) Device3Product Code
- OMHPericardial Patch To Facilitate Revision Surgeries2Product Code
- OMRVessel Guard Or Cover2Product Code
- OTDEndovascular Suturing System2Product Code
- OVJPulse Generator, External Pacemaker, Dual Chamber2Product Code
- PALPulmonic Replacement Heart ValveFProduct Code
- PCKPediatric Ventricular Assist DeviceFProduct Code
- PNJLeadless Pacemaker3Product Code
- PNSShort-Term Intravascular Filter Catheter2Product Code
- PSQIntracardiac Patch Or Pledget, Biologically Derived2Product Code
- PSTAortic Annuloplasty Ring2Product Code
- QABPacing System Analyzer2Product Code
- 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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Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K152633
- 510(k) Type
- Special
- Applicant
- Edwards Lifesciences, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/15/2015
- Days to Decision
- 30 days
- Submission Type
- Summary