FDA.reportPublic FDA data

Mary Rose

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Mary Rose5N2026-01-01One Penumbra Place Alameda CA US 94502

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3520622043486310K250079Ruby XL SystemKRD2025-03-14
3520621383648886K230284Penumbra LP Coil SystemHCG2023-10-25
3520621020083565K192955Penumbra LP Coil SystemHCG2019-11-20
3520621543323481K173614Penumbra Coil 400, Ruby Coil System, POD SystemHCG2018-04-17
3520621908767454K170852POD Packing CoilHCG2017-07-19
3520621150697384K160832Penumbra Smart CoilHCG2016-04-20
3520621201269074K151572Penumbra Smart CoilHCG2015-07-10
3520621314933388K143218Penumbra Smart CoilHCG2015-03-18
3520621746820148K141134POD SYSTEMHCG2014-07-03
3520621224681264K120330PENUMBRA COIL SYSTEM/PENUMBRA COIL 400HCG2012-04-02
3520621897042291K103305PENUMBRA EMBOLIZATION COIL SYSTEMHCG2011-01-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HCG102023-10-25
KRD12025-03-14