FDA.reportPublic FDA data

PIRAEUS MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30317685963031768596PIRAEUS MEDICAL, INC.1N2026-01-017351 Kirkwood Ln N Ste 116 Maple Grove MN US 55369

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3348631974717248K26227770 NeuGlide CatheterQJP2026-09-04
3348631822836351K25104493 NeuFlex CatheterQJP2025-05-23
3348631480106192K24097187 NeuGlide CatheterQJP2024-12-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QJP32026-09-04