FDA.report

Charlene Grilletto

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96800013002808445Charlene Grilletto1N2026-01-01101 E Mill St Quakertown PA US 18951
96814773002807439Charlene Grilletto1N2026-01-01101 E. Mill Street, Suite P Quakertown Quakertown PA US 18951
30048599283004859928Charlene Grilletto1N2026-01-01101 E Mill St Quakertown PA US 18951
30060107123006010712Charlene Grilletto1N2026-01-01101 E Mill St Ste P Quakertown PA US 18951

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
203781213756114P030006PROLIEVE THERMODILATATION SYSTEMMEQ2004-02-19
356351603285729K935198GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONSKNT1994-09-28
356351735713410K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
356351863164497K930091CORDIS REFLEX STEERABLE GUIDEWIREDQX1993-04-07
356351541898588K905639TORQUE HANDLE DEVICE FOR GUIDEWIREDQX1991-02-20
356351778026819K905581SILICONE COATED GUIDEWIRESDQX1991-02-19
203781788009725K890648MALIS BIPOLAR CORD/IRRIGATION TUBING SETGEI1989-03-03
356351996011574K850829WIRE, GUIDE, CATHETERDQY1985-06-26
356351488620868K850828WIRE, GUIDE - MODIFICATIONDQX1985-06-26
356351457663531K850827GUIDE, WIRE, ANGIOGRAPHICDQX1985-06-26
203781130584806K843692FLU VEN I.V. SET 0153-C PERMA-SETFPA1984-10-31
356351892588815K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
248221514505095K253746Enroute 0.014'' Transcarotid GuidewireDQX2026-03-19
356351071905195K242824PTFE GuidewireDQX2024-12-06
248221691656534K182457Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, JDQX2019-04-18
248221009981328K160643ENROUTE 0.014 GuidewireDQX2016-10-18
356351868442439K142397Predicate III GuidewireOCY2014-09-19
356351002566477K142393PREDICATE III GUIDEWIREDQX2014-11-25
248221609826907K141831HYDRAVIEW GUIDEWIREDQX2014-09-04
248221103673949K140536HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIREDQX2014-12-17
356351735196125K140536HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIREDQX2014-12-17
356351692035125K140485MANDREL GUIDEWIREDQX2014-03-27
356351921952984K140482MANDREL GUIDEWIREOCY2014-04-08
248221944618055K122856CHARTER GUIDEWIREDQX2012-10-17
248221580268449K120137VICTORY GUIDEWIRE (32 MODELS)DQX2012-02-14
248221364436222K11345414 WIRE STANDARD, 14 WIRE LSDQX2012-02-24
356351295628143K112381HI TORQUE CONNECT GUIDEWIREDQX2011-11-03
248221345541166K102211CRUISER 18 GUIDEWIREDQX2010-09-03
203781056950876K093526V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM DOMP2010-03-10
248221300786199K083094STREAMER POLYMER GUIDEWIREDQX2009-07-07
248221599756517K082935VISION WIRE CORONARY GUIDEWIREDQX2008-12-04
248221646052094K073082CPS COURIER GUIDEWIREDQX2008-01-09
356351729495975K073082CPS COURIER GUIDEWIREDQX2008-01-09
248221983574482K061171SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XXDQX2006-06-02
248221478456109K060551BRIVANT GUIDEWIREDQX2006-06-07
356351001611463K011084MANDREL GUIDEWIRE ASSEMBLYDQX2001-05-10
630981281275741
630981967223393
356351006148669
203781016615304
356351017434909
203781020449651
203781041247322
356351042929078
203781045608786
248221056842126
356351061020423
356351061051133
203781071476859
630981073486357
203781097580246
356351115278350
203781144071704
203781146784951
356351166214762
356351187804806
203781188830420
203781314162133
203781364050580
356351364791137
203781367212826
203781377744403
203781397701769
203781404151161
203781405904553
356351422111551
203781456649652
203781459707084
356351486500250
203781487027925
203781502862130
356351507896074
356351511730936
356351519127915
203781519408860
630981528180050
203781567436368
203781582382001
356351585028973
203781591809810
203781597339739
203781623560864
203781662813258
356351684368159
203781699768299
203781709867923
203781720268046
356351737212292
203781757863545
203781769085253
356351774907525
203781796860017
356351801084635
203781814286300
203781818189891
203781819596947
356351849096693
203781888311541
356351908864408
203781915628901
356351950353196
356351957333446
356351974710576
356351980360824
203781983582201
630981995197119
356352002731230
203782039502566
203782046468787

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DQX282026-03-19
OCY22014-09-19
OMP12010-03-10
MEQ12004-02-19
KNT11994-09-28
GEI11989-03-03
DQY11985-06-26
FPA11984-10-31