FDA.reportPublic FDA data

Aaron Dunbar

FDA Registration(s)#

Registration, FEI, Name table
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
96812603002806565Aaron 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 key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
267581511121162P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
267581517525685P980033WALLSTENT ENDOPROSTHESISQKJ2001-11-16
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
267581352338383P950020FLEXATOME CUTTING BALLOONNWX2000-04-18
267581747021444P940019WALLSTENT(R) ILIAC ENDOPROSTHESISNIO1996-05-28
267581419367627P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMMIR1995-09-29
267371923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
267581923360514P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB1994-10-28
267341042955031P900056ROTABLATOR(R)MCX1993-05-28
267371042955031P900056ROTABLATOR(R)MCX1993-05-28
267581291648365P230035AGENT Paclitaxel-Coated Balloon CatheterOOB2024-02-29
267371515190534P230030FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,QZI2024-01-30
267581515190534P230030FARAPULSE™ 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
267581382237580P220032POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, AccessoriesOAE2023-08-08
267581580189764P190019Ranger™ Paclitaxel-Coated PTA Balloon CatheterONU2020-10-30
267581219392652P180029LOTUS Edge Valve SystemNPT2019-04-23
267581040963809P180011Eluvia Drug-Eluting Vascular Stent SystemNIU2018-09-18
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
267581846987198P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD2016-02-24
267581719286576P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2015-10-02
267581833215550P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEMNIP2015-07-21
1221971730363118P140004SUPERION INTERSPINOUS SPACERNQO2015-05-20
267581649464100P130030REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIREMAF2026-03-10
267581951386063P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYNGV2015-03-13
1221971740614124P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMLWS2012-09-28
267581310175420P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEMNIO2012-04-13
267581144344264P110010PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2011-11-22
267581325594545P090003EXPRESS LD ILIAC PREMOUNTED STENT SYSTEMNIO2010-03-05
267341645200515P080032ALAIR BRONCHIAL THERMOPLASTY SYSTEMOOY2010-04-27
267581384799466P060006BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEMNIN2008-12-11
267581357706852P050019CAROTID WALLSTENT MONORAIL ENDOPROSTHESISNIM2008-10-23
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
267581842603510P020025EP 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
267581348099187K992373ORBITER 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
267581543774459K982184WALLSTENT ENDOPROSTHESISJCT1998-07-21
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
267581290731583K980453SCHNEIDER GUIDER SOFTIP GUIDING CATHETERSDQY1998-08-11
267371874789914K974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERDQY1998-02-19
267581258766136K974541MODIFIED URETERAL INDWELLING CATHETER/STENTFAD1998-02-09
267581952094978K973826SPHINCTEROTOMEKNS1997-12-05
267341956723555K973645RENEGADE FIBER BRAIDED MICROCATHETERKRA1997-11-19
267371956723555K973645RENEGADE FIBER BRAIDED MICROCATHETERKRA1997-11-19
267581956723555K973645RENEGADE FIBER BRAIDED MICROCATHETERKRA1997-11-19
267371073607925K971265VIKING DIAGNOSTIC ELECTRODE CATHETERDRF1997-10-23
267581073607925K971265VIKING DIAGNOSTIC ELECTRODE CATHETERDRF1997-10-23
267371005785964K971254TRANSEND EX PLATINUM GUIDEWIREDQX1997-07-01
267581005785964K971254TRANSEND EX PLATINUM GUIDEWIREDQX1997-07-01
267371708549503K970823SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETERDQY1997-06-03
267581472452946K970278MICROVASIVE GOLD PROBEKNS1997-04-11
267581066875510K970054TANDEMRXGCJ1997-02-10
267581971677978K965147BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESISFGE1997-06-30
267371155304903K964611TRANSEND GUIDEWIREDQX1997-01-28
267581155304903K964611TRANSEND 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
267581904890464K945379PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATINGDQX1995-06-05
267371611241927K944959AMPLATZ SUPER STIFF GUIDEWIREOCY1994-11-04
267371543096658K944677SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIESDQX1995-02-08
267581543096658K944677SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIESDQX1995-02-08
267371421215756K944290CATHETERS, BILIARY CATHETERS, UROLOGICALFFA1994-12-08
267581421215756K944290CATHETERS, BILIARY CATHETERS, UROLOGICALFFA1994-12-08
267371290657277K942453GUIDE WIREDQX1994-12-08
267581290657277K942453GUIDE WIREDQX1994-12-08
267371096888801K942333SCIMED EN TRE' III PTCA GUIDE WIREDQX1994-08-31
267582005668912K941853PASSPORTEZN1994-09-12
267371467796060K941710SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIESDQX1994-09-01
267581467796060K941710SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIESDQX1994-09-01
267371759012443K935997PLATINUM PLUS GUIDEWIREDQX1994-06-17
267581759012443K935997PLATINUM PLUS GUIDEWIREDQX1994-06-17
267371355311752K934122SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIESDQX1993-10-07
267581355311752K934122SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIESDQX1993-10-07
267371505458086K933334MAGIC TORQUE GUIDEWIREDQX1994-01-26
267581505458086K933334MAGIC TORQUE GUIDEWIREDQX1994-01-26
267372060967144K931650MICROVASIVE INSURG GEENEN CBD GUIDE WIREOCY1993-06-25
267581495323276K930348COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEMFDX1993-09-03
267581615269001K930022SPHINCTEROTOMEFDI1993-04-27
267371634026534K924608HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERSFGE1994-01-26
267581634026534K924608HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERSFGE1994-01-26
267371166667921K924163EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELECDRF1993-09-03
267581166667921K924163EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELECDRF1993-09-03
267341637934525K92257310 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGEMAV1992-12-08
267581637934525K92257310 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGEMAV1992-12-08
267371131462748K921872
267581488064099K915719ANGEION ENDOSCOPIC VALVE SEALODC1992-02-18
267341159729380K913871FLOSWITCH(R) HPDQO1991-11-25
267371159729380K913871FLOSWITCH(R) HPDQO1991-11-25
267581159729380K913871FLOSWITCH(R) HPDQO1991-11-25
267371040421232K912213
267371414869344K900765STEEROCATH(TM)DRF1990-05-07
267581893368967K891968ESP RADIATION REDUCTION EXAMINATION GLOVESLZC1989-05-22
267581879326167K870694VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETERKOD1987-03-10
267581094212025K860337VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH.KOD1986-03-25
267581360584022K851144URETERAL DILATION SETEZN1985-04-09
267371303032891K843012WIREGUIDE OR GUIDEWIREDQX1984-11-29
267371414966292K840033HYPODERMIC NEEDLES & STYLETSFMI1984-04-05
267581964142755K833417ENDOSCOPIC RETROGRADEODD1983-11-28
267581046338328K830840OPEN ENDED URETERAL CATHETERGBM1983-04-06
267581142898123K820870URETERAL STANT SETFAD1982-04-26
267371247188661K820865VAN-TEC FASCIAL DILATORGCC1982-05-05
267371047144046K811378PERCUTANEOUS DRAINING CATHETERGBW1981-06-02
267581910885513K780872CYTOLOGY BRUSHBTG1978-09-07
267341912454946K260771TruSelect™ 2.6 MicrocatheterKRA2026-05-15
267581912454946K260771TruSelect™ 2.6 MicrocatheterKRA2026-05-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX602022-12-19
FGE362025-07-03
DRF292025-06-27
DQY252024-02-01
GEH212024-10-18
KRD212023-06-27
LIT182024-07-10
KRA162026-05-15
DQO142015-10-29
LOX132022-03-24
KNS122025-06-11
DYB102025-03-20
GEX82025-07-09
ODC72025-10-09
FAD72025-04-15
JCT72023-07-14
ODG72022-12-30
ESW62024-04-29
MCW62022-09-06
FDI62020-10-08
MJN62014-07-22
GEI62014-04-17
QEW52020-10-02
QEZ52012-06-06
OVB42026-02-10
MXD42025-09-12
PKL42025-02-06
DRE42024-07-12
FGB42024-07-01
MQR42024-03-08
OTN42023-06-29
FBN42020-05-21
OAD42016-02-24
MAV42014-04-17
DXF32024-11-01
OCW32023-06-29
LQR32021-05-26
FDT32019-12-13
EOQ32019-03-08
QEY32018-11-26