FDA.reportPublic FDA data

MINNETRONIX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21338103000203066MINNETRONIX, INC.1N2026-01-011635 ENERGY PARK DR. Saint Paul MN US 55108

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
546741813458844P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX1999-03-12
546741856910205P150026HEARTLIGHT ENDOSCOPIC ABLATION SYSTEMOAE2016-04-01
546741596688476P130028ALGOVITA SPINAL CORD STIMULATION SYSTEMLGW2015-11-20
546741253980216P100047HEARTWARE VENTRICULAR ASSIST SYSTEMDSQ2012-11-20
546741131096359K181699Level 1 Convective WarmerDWJ2018-07-26
546741098122869K181292PrimeSightâ„¢ UNITY 9000 Video Processor, PrimeSightâ„¢ UNITY 9100 Video ProcessorEOX2018-11-15
546742051884831K170585SkylifeLBI2017-10-27
546741169159078K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel ApplicatorNRB2016-12-22
546741077684353K162407L300 Go SystemGZI2017-01-27
546742012650941K152596Intact® Gen2 SystemKNW2016-02-15
546741272756809K131583THERMOCHEM HT-2000MLW2013-10-03
546741278783836K113351CORTRAK ENTERAL ACCESS DEVICEKNT2012-01-10
546741569357719K111285AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTINGGEI2011-09-09
546741246726751K091310ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682GEI2010-08-11
546741952937029K090986STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)NDN2009-12-30
546741563300586K083184TEARLAB OSMOLARITY SYSTEMOND2009-05-14
546741142238971K061369TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500DWA2006-08-22
546741492232899
546741513370881
546741992804670
546741036746297
546741080938181
546741104368730
546741131096359
546741186067714
546741246726751
546741253980216
546741278783836
546741328160897
546741365493481
546741387232200
546741498256866
546741590083024
546741672707766
546741678093326
546741739742026
546741745711757
546741774853312
546741799939255
546741813458844
546741817273428
546741856910205
546741858853130
546741906965444
546741971273078
546742003550086
546742012650941
546742036805319
546742051884831
546742065769765

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI22011-09-09
EOX12018-11-15
DWJ12018-07-26
LBI12017-10-27
GZI12017-01-27
NRB12016-12-22
OAE12016-04-01
KNW12016-02-15
LGW12015-11-20
MLW12013-10-03
DSQ12012-11-20
KNT12012-01-10
NDN12009-12-30
OND12009-05-14
DWA12006-08-22
MCX11999-03-12

PMN#