FDA.reportPublic FDA data

Keith Krohn

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040916153004091615Keith Krohn1N2026-01-0126531 Ynez Road M/S TCC-215 Temecula CA US 92591
30095647663009564766Keith Krohn1N2026-01-0126531 Ynez Road M/S TCC-215 Temecula CA US 92591

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1201801971992102P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
1201801867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
1201801961512206P230036Esprit™ BTK Everolimus Eluting Resorbable Scaffold SystemNXW2024-04-26
1201801457511207P150023ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEMPNY2016-07-05
1201801297266658P130005DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEMMCX2013-10-21
1201801067542151P120020SUPERA PERIPHERAL STENT SYSTEMNIP2014-03-28
1201801792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
1201801309805090P110028ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEMNIO2012-02-22
1201801542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
1201801469892557P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN2011-07-20
1201801128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
1201801727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
1201801559811470P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB2005-12-21
1201801681222287P040038XACT CAROTID STENT SYSTEMNIM2005-09-06
1201801479612281P040012ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEMNIM2004-08-30
1201801963635576P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
1201801233166198K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQX1999-10-28
1201801589735738K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331DTL1999-06-09
1201801208749907K990639ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.DQX1999-03-25
1201801267300283K984394ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATINGDQX1999-03-08
1201801757061627K982876HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282DQX1998-11-10
1201801210905110K981381ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1DQX1998-07-15
1201801576736442K980119ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIREDQX1998-03-20
1201801887303636K972142ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATINGDQX1997-08-25
1201802053257521K971815ASC BALANCE MIDDLEWEIGHT GUIDE WIREDQX1997-07-09
1201801439277137K963702ACS HI-TORQUE IRON MAN GUIDE WIREDQX1997-01-22
1201801725321618K962495INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)MAV1996-09-12
1201801879529914K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)MAV1996-05-08
1201801748988175K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITSDQX1995-05-15
1201801449155535K942066ACS HI-TORQUE EXTRA S'PORT GUIDE WIREDQX1994-07-18
1201801426393649K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
1201801092773492K934624ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVEDYB1994-04-13
1201801429531772K934602ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIREDQX1993-12-16
1201801155385726K934339LOC GUIDE WIRE EXTENSIONDQX1993-12-09
1201801452023796K925381ACS HI-TORQUE BALANCE(TM) GUIDE WIREDQX1993-02-12
1201801071559481K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDF1992-01-27
1201801077458785K914138ONTRACDQX1991-12-13
1201801820946517K913631.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIREDQX1991-10-28
1201801791893216K913353VASCULAR GUIDE WIREDQX1991-10-23
1201801900612166K910645DISPOSABLE PATIENT CABLEDSA1991-05-07
1201802019477494K902755.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIPDQX1990-09-04
1201801250275189K894343DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMODYB1989-09-26
1201801637217174K881897ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GWDQX1988-08-03
1201801229520279K881787ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIREDQX1988-07-25
1201801708793242K875059DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODELDF1988-02-12
1201801269826574K854261ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVESDTL1985-12-04
1201801711066651K850827GUIDE, WIRE, ANGIOGRAPHICDQX1985-06-26
1201801662996101K221057Viatrac 14 Plus Peripheral Dilatation CatheterLIT2022-05-05
1201801429962158K220634NC TREK NEO Coronary Dilatation CatheterLOX2022-06-30
1404091429962158K220634NC TREK NEO Coronary Dilatation CatheterLOX2022-06-30
1201801649037650K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW2022-04-27
1201801102114316K220243Ultiri Measurement SystemDQK2022-04-30
1201801242710329K213565JETi AIO Peripheral Thrombectomy SystemQEZ2022-02-01
1201801295388193K211240ViperCross Support CathetersDQY2021-08-26
1201801295788282K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy systemMCW2021-09-14
1201801734228358K210282WIRION Embolic Protection SystemNTE2021-03-03
1201801340459919K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy SystemMCW2020-11-19
1201801996188646K201881CoroFlow Cardiovascular SystemDQK2020-11-13
1201801446962697K201834HI-TORQUE PROCEED Guide Wire FamilyDQX2020-07-30
1201801264630936K200198WIRIONNTE2020-03-18
1201801652285026K193126HI-TORQUE InfilTrac Guide Wire FamilyDQX2019-12-11
1201801980617295K192267ILUMIEN System with AptiVue Software version D.3DQO2019-12-17
1201801739588254K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE2019-07-25
1201801630753771K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy SystemMCW2019-07-02
1201801645630776K183000ViperCath XC Peripheral Exchange CatheterDQY2018-12-29
1201801112779326K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW2018-12-13
1201801117700999K180558PressureWire XDXO2018-03-28
1404091117700999K180558PressureWire XDXO2018-03-28
1201801995554121K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy SystemMCW2018-04-17
1201801707175656K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation CatheterLOX2018-08-24
1404091707175656K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation CatheterLOX2018-08-24
1201801682429855K173795HI-TORQUE TurnTrac Guide Wire FamilyDQX2018-01-12
1201801590269801K172073Hi-Torque Command 18 Guide WireDQX2017-08-25
1201801778577295K170792Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2017-06-09
1201801081494603K161985Steerable Guide CatheterDRA2016-08-07
1201801053517063K153086RX ACCUNET Embolic Protection SystemNTE2015-11-20
1201801953461256K152709HI-TORQUE BALANCEDQX2015-10-21
1201801543877241K152694Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2015-10-21
1201801229024094K151317Armada 18 PTA CatheterLIT2015-07-06
1201801536318531K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PADMCW2015-06-10
1201801975326275K150732Diamondback 360 Peripheral Orbital Atherectomy SystemMCW2015-04-13
1201801034680055K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterNQQ2015-05-05
1201801268601531K142415Hi-Torque JET Guide Wire FamilyDQX2014-12-19
1201802001970009K141782HI-TORQUE VERSATURN GUIDE WIREDQX2014-08-07
1201801168245339K140536HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIREDQX2014-12-17
1201801029558099K140327ULTIMUM EV HEMOSTASIS INTRODUCERDYB2014-03-11
1201801141040645K133999DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEMMCW2014-02-28
1201801361316709K133399DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEMMCW2013-11-22
1201801998324692K123279MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDINLOX2013-01-30
1404091998324692K123279MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDINLOX2013-01-30
1201801188993564K123067PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILYDQX2013-01-29
1201801621024127K122573HI-TORQUE COMMAND GUIDE WIRE FAMILYDQX2012-11-20
1201801109450141K121352ARMADA 14XXT PTA CATHETERDQY2012-08-15
1404091109450141K121352ARMADA 14XXT PTA CATHETERDQY2012-08-15
1201801588228274K121222TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETERLOX2012-06-22
1404091588228274K121222TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETERLOX2012-06-22
1201801318353310K113658AMPLATZER VASCULAR PLUG 4KRD2012-06-12
1201801523521089K113464NC TREK OTW CORONARY DILATATION CATHETERLOX2012-03-06
1404091523521089K113464NC TREK OTW CORONARY DILATATION CATHETERLOX2012-03-06
1201801774467128K112957HI-TORQUE POWERTURNDQX2011-11-08
1201801489125777K112381HI TORQUE CONNECT GUIDEWIREDQX2011-11-03
1201801045602371K111899ARMADA 35/35LL PTA CATHETERLIT2011-10-03
1404091045602371K111899ARMADA 35/35LL PTA CATHETERLIT2011-10-03
1201801128737480K111388DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEMMCW2011-07-26
1201801503854714K111092ENGAGE/ENGAGE TR INTRODUCERSDYB2011-06-09
1201801542031674K110389STEALTH 360 ORBITAL PAD SYSTEMMCW2011-03-11
1201801265416256K110134NC TREK RX CORONARY DILATATION CATHETERLOX2011-02-11
1404091265416256K110134NC TREK RX CORONARY DILATATION CATHETERLOX2011-02-11
1201802039035464K103153VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETERLOX2010-12-30
1404092039035464K103153VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETERLOX2010-12-30
1201801305441425K103110MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETERLOX2011-01-10
1404091305441425K103110MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETERLOX2011-01-10
1201801470913046K103101HI-TORQUE BALANCE MIDDLEWEIGHT ELITEDQX2011-02-10
1201801287874981K102705ARMADA 14 PTA CATHETERLIT2010-12-07
1201801154804276K101648HI-TORQUE WINN GUIDE WIRE FAMILYDQX2010-07-08
1201801541567934K101116HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITHDQX2010-06-23
1201801482156564K091137ULTIMUM/ENGAGE/ENGAGE TRDYB2009-04-22
1201801260015580K083793STEERABLE GUIDE CATHETERDRA2009-04-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX462020-07-30
LOX182022-06-30
MCW142022-04-27
DYB72014-03-11
LIT62022-05-05
DQY52021-08-26
NTE52021-03-03
KRD42012-06-12
FGE32008-08-18
DQK22022-04-30
DXO22018-03-28
DRA22016-08-07
NIQ22011-11-01
MGB22005-12-21
MAF22003-07-16
DTL21999-06-09
MAV21996-09-12
LDF21992-01-27
QEZ12022-02-01
DQO12019-12-17
PNY12016-07-05
NQQ12015-05-05
NIP12014-03-28
NKM12013-10-24
MCX12013-10-21
NIO 12012-07-31
NIO12012-02-22
NIN 12011-07-20
NIM12005-09-06
NIM 12004-08-30
DSA11991-05-07