FDA.reportPublic FDA data

Kathy Berg

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30125525323012552532Kathy Berg1N2027-01-0115900 Valley View Ct Sylmar CA US 91342

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2238281461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
2238281364977690P130026TACTICATH QUARTZ SETOAE2014-10-24
2238281906099585P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
2238281599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
2238281284508201K230286Assert-IQ™ Insertable Cardiac MonitorMXC2023-05-17
2238281071867675K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software LicenseDQK2020-06-26
2238281406995437K090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078DRB2009-04-01
2238281454788660

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MXC12023-05-17
DQK12020-06-26
OAE12014-10-24
OAD12012-01-25
DRB12009-04-01
NIK12004-06-30
LWS11993-04-30