FDA.report

Aaron Dunbar

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96166843002913962Aaron Dunbar1N2026-01-01300 Boston Scientific Way Marlborough MA US 01752
96166933002618605Aaron Dunbar1N2026-01-01300 Boston Scientific Way Marlborough MA US 01752
96167933002843919Aaron Dunbar1N2026-01-01300 Boston Scientific Way Marlborough MA US 01752
30048592413004859241Aaron Dunbar1N2026-01-01300 Boston Scientific Way Marlborough MA US 01752
30051111023005111102Aaron Dunbar1N2026-01-01300 Boston Scientific Way Marlborough MA US 01752
30142223683014222368Aaron Dunbar1N2026-01-01300 BOSTON SCIENTIFIC WAY Marlborough MA US 01752
30197516103019751610Aaron Dunbar1N2026-01-01300 Boston Scientific Way Marlborough MA US 01752

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
267371607541825P980003CHILLI COOLED RF ABLATION SYSTEMLPB1999-02-02
1221971261241681P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMLWS1997-07-18
267371923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
267341042955031P900056ROTABLATOR(R)MCX1993-05-28
267371042955031P900056ROTABLATOR(R)MCX1993-05-28
267371515190534P230030FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,QZI2024-01-30
267371382237580P220032POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, AccessoriesOAE2023-08-08
1221971401702589P150031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMNHL2017-12-08
1221971201497276P150012IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADLWP2016-04-25
267371846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
1221971730363118P140004SUPERION INTERSPINOUS SPACERNQO2015-05-20
1221971740614124P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMLWS2012-09-28
267341645200515P080032ALAIR BRONCHIAL THERMOPLASTY SYSTEMOOY2010-04-27
1221971259418821P030017PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMLGW2004-04-27
1221971069547642P030005CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARENKE2004-01-26
267371842603510P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
1221971452976857P010012CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLNIK2002-05-02
1221971012192267N970003PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARELWP1999-06-03
267371319344908K994252INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIREDYB2000-01-04
2338811219869852K993965CRYO-HITGEH2000-02-18
267371348099187K992373ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLEDRF1999-11-05
2338812013312378K991517CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5GEH1999-07-27
2338811789109912K991272CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND EGEH1999-07-12
267371594973796K981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERDQO1998-08-18
2338811023045835K980913CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5GEI1998-07-01
267371290731583K980453SCHNEIDER GUIDER SOFTIP GUIDING CATHETERSDQY1998-08-11
267371874789914K974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERDQY1998-02-19
267341956723555K973645RENEGADE FIBER BRAIDED MICROCATHETERKRA1997-11-19
267371956723555K973645RENEGADE FIBER BRAIDED MICROCATHETERKRA1997-11-19
267371073607925K971265VIKING DIAGNOSTIC ELECTRODE CATHETERDRF1997-10-23
267371005785964K971254TRANSEND EX PLATINUM GUIDEWIREDQX1997-07-01
267371708549503K970823SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETERDQY1997-06-03
267371155304903K964611TRANSEND GUIDEWIREDQX1997-01-28
267341427360051K964284STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEMDTK1997-01-06
267341835712619K955396STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEMDTK1996-02-09
267371764732899K953750CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGDRF1996-03-11
267371904890464K945379PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATINGDQX1995-06-05
267371611241927K944959AMPLATZ SUPER STIFF GUIDEWIREOCY1994-11-04
267371543096658K944677SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIESDQX1995-02-08
267371421215756K944290CATHETERS, BILIARY CATHETERS, UROLOGICALFFA1994-12-08
267371290657277K942453GUIDE WIREDQX1994-12-08
267371096888801K942333SCIMED EN TRE' III PTCA GUIDE WIREDQX1994-08-31
267371467796060K941710SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIESDQX1994-09-01
267371759012443K935997PLATINUM PLUS GUIDEWIREDQX1994-06-17
267371355311752K934122SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIESDQX1993-10-07
267371505458086K933334MAGIC TORQUE GUIDEWIREDQX1994-01-26
267372060967144K931650MICROVASIVE INSURG GEENEN CBD GUIDE WIREOCY1993-06-25
267371634026534K924608HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERSFGE1994-01-26
267371166667921K924163EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELECDRF1993-09-03
267341637934525K92257310 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGEMAV1992-12-08
267371131462748K921872
267341159729380K913871FLOSWITCH(R) HPDQO1991-11-25
267371159729380K913871FLOSWITCH(R) HPDQO1991-11-25
267371040421232K912213
267371414869344K900765STEEROCATH(TM)DRF1990-05-07
267371303032891K843012WIREGUIDE OR GUIDEWIREDQX1984-11-29
267371414966292K840033HYPODERMIC NEEDLES & STYLETSFMI1984-04-05
267371247188661K820865VAN-TEC FASCIAL DILATORGCC1982-05-05
267371047144046K811378PERCUTANEOUS DRAINING CATHETERGBW1981-06-02
267341912454946K260771TruSelect™ 2.6 MicrocatheterKRA2026-05-15
267341171472521K260119SpaceOAR Vue System (SV-2101)OVB2026-02-10
267341553500788K252910Orca Air/Water and Suction ValvesODC2025-10-09
1221971530353211K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)MXD2025-09-12
2139591201854817K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser FibersGEX2025-07-09
1221971844011106K251273Asurys Fluid Management SystemHIG2026-03-27
1221971403031099K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)GXD2025-08-07
2338811726562200K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)GEH2024-10-18
3036911274607251K242076VersaCross™ RF WireDXF2024-11-01
3036911148765765K241720VersaCross Connect™ Transseptal DilatorDRE2024-07-12
267371004157561K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterDRF2024-11-01
3036911143697980K233647VersaCross Connect™ Transseptal DilatorDRE2023-12-14
267371188045820K232651BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterDRF2023-09-29
2338811559155674K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)GEH2023-11-22
1221971875770714K231328LUX-Dx II (M302); LUX-Dx II+ (M312)MXD2023-08-19
3036911261302812K231227SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathDYB2023-12-20
267341618939977K230706EMBOLD™ Soft Detachable Coil SystemKRD2023-06-27
267371618939977K230706EMBOLD™ Soft Detachable Coil SystemKRD2023-06-27
267371991451479K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableDRF2023-04-25
267371247745980K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorDRA2023-03-22
3036911352000752K221351Mechanical GuidewireDQX2022-12-19
267341814883300K220962ROTAPRO Rotational Atherectomy SystemMCW2022-09-06
267371814883300K220962ROTAPRO Rotational Atherectomy SystemMCW2022-09-06
267371202224516K220796IntellaMap Orion High Resolution Mapping CatheterDRF2022-06-10
2139591978526363K220629Emerge Monorail PTCA Dilatation CatheterLOX2022-03-24
3036911848847969K220414VersaCross Connect Transseptal DilatorDYB2022-05-09
3036911814346843K213582Epicardial Access SystemDYB2022-06-30
267341871570867K213398EMBOLD Fibered Detachable Coil SystemKRD2022-04-12
267371871570867K213398EMBOLD Fibered Detachable Coil SystemKRD2022-04-12
2139591016183523K212582SpyGlass Discover Balloon Dilation CatheterGCA2022-05-06
267371336527414K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenbergFAD2022-11-10
267371680595425K211494Polaris X Unidirectional Steerable Diagnostic CatheterDRF2021-09-14
1221971880824328K210608LUX-Dx Insertable Cardiac MonitorMXD2021-05-25
267341767278027K203276Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)NOY2021-04-20
267341649144564K202224SpaceOAR SystemOVB2020-08-28
267371553170679K202218ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation DeviceQEW2020-10-02
267341854162550K201792TRUSELECT MicrocatheterKRA2020-07-28
267371854162550K201792TRUSELECT MicrocatheterKRA2020-07-28
3036911803424653K201288ExpanSure Large Access Transseptal DilatorDRE2020-06-12
1221971828727678K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerFBN2020-05-21
267341103682172K200404ORISE ProKnifeKNS2020-12-03
1221971183995703K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - USMXD2020-06-26
267371333805275K192360IntellaMap Orion High Resolution Mapping CatheterDRF2019-10-25
267371095649104K191446Ureteral Stent Systems, Biliary Drainage CathetersFAD2020-01-02
3036911497600628K190688VersaCross Steerable Sheath, VersaCross Transseptal DilatorDYB2019-04-17
267341332826677K190401MAMBA and MAMBA Flex MicrocathetersDQY2019-03-15
3036911880031556K183655VersaCross Transseptal SheathDYB2019-05-20
3036911228084478K183649Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology CableDRF2019-06-07
1221971108039872K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital ControllerFBN2019-01-22
3036911844604813K183632Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology CableDRF2019-06-07
1221971434057808K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm DeviceFAE2019-04-16
267341817544194K182971SpaceOAR Vue HydrogelOVB2019-07-19
267371359626749K182315Magic Torque DLVR GuidewireDQX2018-09-26
267341975188294K182275Seal Single Use Biopsy ValveOCX2018-09-13
3036911407359329K182064ExpanSure Transseptal Dilation SystemDRE2019-03-21
2338811046097172K181741IceSphere 1.5 CX Cryoablation NeedleGEH2018-07-30
267341739291824K181465SpaceOAR SystemOVB2018-06-25
267371900145135K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireDQX2018-04-12
2139591900145135K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireDQX2018-04-12
267371647694687K180726Savion DLVR Guidewire, Savion FLX GuidewireDQX2018-06-18
267341832682223K180102Embozene Color-Advanced MicrospheresNOY2018-04-19

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DQX372022-12-19
GEH212024-10-18
DRF182024-11-01
KRD162023-06-27
KRA112026-05-15
DQY112019-03-15
DQO92015-10-29
DYB82023-12-20
FGE72017-10-04
MCW62022-09-06
GEX52025-07-09
OVB42026-02-10
MXD42025-09-12
DRE42024-07-12
MJN42014-07-22
DXF32024-11-01
LOX32022-03-24
MAV32014-04-17
GEI32012-11-07
ODC22025-10-09
GXD22025-08-07
FAD22022-11-10
NOY22021-04-20
FBN22020-05-21
OCX22018-09-13
LWP22016-04-25
OAD22016-02-24
LIT22014-08-21
LWS22012-09-28
NAJ22010-04-16
DSA22002-12-31
LPB21999-02-02
DTK21997-01-06
OCY21994-11-04
MCX21993-05-28
HIG12026-03-27
DRA12023-03-22
GCA12022-05-06
KNS12020-12-03
QEW12020-10-02