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510(k) K231096

Automatic Continuous Effusion Shunt (ACES) System ACES System by Pleural Dynamics, Inc. — Product Code KPM

K231096 is an FDA 510(k) premarket notification submitted by Pleural Dynamics, Inc. for the device "Automatic Continuous Effusion Shunt (ACES) System ACES System". The FDA issued a decision of Substantially Equivalent on August 18, 2023. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2023
Date Received
April 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Peritoneal
Device Class
Class II
Regulation Number
876.5955
Review Panel
GU
Submission Type

Other clearances for product code KPM

  • K170405 — BD Curve Ascites Shunt (November 2, 2017)
  • K012235 — DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PU (October 4, 2001)
  • K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT (July 12, 2001)
  • K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (June 1, 2001)
  • K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHU (January 2, 2001)
  • K973129 — DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS (March 17, 1998)
  • K962814 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (April 14, 1997)
  • K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (February 18, 1994)
  • K901360 — LEVEEN PERITINEO-VENOUS SHUNT (August 21, 1990)
  • K894794 — AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP (November 21, 1989)

FDA data resources