DeviceClearance

Automatic Continuous Effusion Shunt (ACES) System ACES System— 510(k) K231096

Substantially Equivalent

Pleural Dynamics, Inc.

FDA 510(k) clearance K231096 for Automatic Continuous Effusion Shunt (ACES) System ACES System, Substantially Equivalent on 2023-08-18. Applicant: Pleural Dynamics, Inc..

Clearance details

Applicant
Pleural Dynamics, Inc.
Product code
Code KPM
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wayzata, MN, US
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