FDA.reportPublic FDA data

Pleural Dynamics, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30293007533029300753Pleural Dynamics, Inc.1N2026-01-01952 Medina Road Wayzata MN US 55391

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3201462013772965K231096Automatic Continuous Effusion Shunt (ACES) System ACES SystemKPM2023-08-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPM12023-08-18

PMN#

GUDID#