FDA.reportPublic FDA data

BIOMERICS Advanced Catheter

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121591653012159165BIOMERICS Advanced Catheter1N2026-01-0110351 Xylon Avenue N Brooklyn Park MN US 55445

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1879581144706966K221390BNLE Access GuidewireDQX2023-04-28
1879581353612562K162925AcQGuide Steerable SheathDRA2017-04-06
1879581193624784
1879581454201662
1879581484270163
1879582008212776
1879582032961185
1879581038163713
1879581178990378
1879581411909970
1879581608913068
1879581676826466
1879581981919881
1879582056089531

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX12023-04-28
DRA12017-04-06