FDA.reportPublic FDA data

Kristen Ortiz

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96809043007019930Kristen Ortiz1N2026-01-01850 W Rio Salado Pkwy Tempe AZ US 85281

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1089661913001156K971753DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500DWM1997-06-27
1089661109410890K962907SKINNY,FRANSEEN,WESCOTT NEEDLESKNW1996-10-23
1089661916948442K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
1089661561372225K960064TEMNO ACHIEVE BIOPSY NEEDLEKNW1996-04-05
1089661528109219K930217BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLEFMI1994-02-28
1089661628493548K926559PROACT BIOPSY NEEDLE ENCHANCEMENTSFCG1993-03-22
1089662018570588K913306BONE-TEMNO/STERNUM-TEMNOLWE1991-11-01
1089661654366598K902319BAUER TEMNO BIOPSY NEEDLEFCG1990-09-06
1089661203061377K813338BIOPSY NEEDLES & TRAYSFSH1982-01-28
1089661209023466K171953Bard Mission Disposable Core Biopsy InstrumentKNW2017-09-14
1089662018136799K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration NeedleKNW2017-09-11
1089661381400838K141965PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KITDWM2015-07-02
1089661994543245K141722CAREFUSION GOLD TISSUE MARKERNEU2015-01-23
1089661646559130K141552ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMSKNW2014-09-05
1089661369000415K133948BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENTKNW2014-02-21
1089661103361818K122422PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCERPNG2012-10-24
1089661016982245K121849PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEEDWM2012-10-18
1089661680384327K113854PLEURX PERITONEAL CATHETER SYSTEMPNG2012-03-19
1089661735363321K112831PLEURX PLEURAL CATHETER SYSTEMSDWM2012-02-16
1089662005553468K051711PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITSPNG2005-11-15
1089661417414920K051084DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINEDWM2005-06-13
1089661908877086K024120MODIFICATION TO TEMNO BIOPSY NEEDLESFCG2003-01-15
1089661517860002K003370JAMSHIDI MARROW ACQUISITION CRADLEKNW2000-11-22
1089661119251219
1089661177232623
1089661225193571
1089661559680773
1089661642553386
1089662006761615
1089661010869537
1089661203061377
1089661209023466
1089661215496759
1089661369000415
1089661517860002
1089661528109219
1089661820982000
1089661872056895
1089661972503093
1089662018136799
1089662028561632

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNW82017-09-14
DWM52015-07-02
PNG32012-10-24
FCG32003-01-15
NEU12015-01-23
FMI11994-02-28
LWE11991-11-01
FSH11982-01-28