Automatic Continuous Effusion Shunt (ACES) System ACES System— 510(k) K231096
Substantially EquivalentPleural 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.. Device class: 2.
Clearance details
- Applicant
- Pleural Dynamics, Inc.
- Product code
- Code KPM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5955
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayzata, MN, US
Recent devices under product code KPM
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- K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
- K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
Data sourced from openFDA. This site is unofficial and independent of the FDA.