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510(k) K231096

Device
Automatic Continuous Effusion Shunt (ACES) System ACES System
Applicant
Pleural Dynamics, Inc.
510(k) number
K231096
Product code
KPM
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-18
Date received
2023-04-18
Regulation
876.5955
Classification name
Shunt, Peritoneal
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Martin Mayse
Address
952 Medina Rd. Wayzata MN US 55391 55391

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KPM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170405BD Curve Ascites ShuntCare Fusion2017-11-02
K012235DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver Biomedical, Inc.2001-10-04
K011862DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNTDenver Biomedical, Inc.2001-07-12
K011020DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver Biomedicals, Inc.2001-06-01
K003451DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES TDenver Biomedicals, Inc.2001-01-02
K973129DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITSDenver Biomaterials, Inc.1998-03-17
K962814DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver Biomaterials, Inc.1997-04-14
K913728DENVER(R) PERITONEO-SUBCLAVIAN SHUNTDenver Biomedicals, Inc.1994-02-18
K901360LEVEEN PERITINEO-VENOUS SHUNTBd Becton Dickinson Vacutainer Systems Preanalytic1990-08-21
K894794AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMPVitaid, Ltd.1989-11-21
K894756DENVER PERITONEO-VENUS SHUNTCodman & Shurtleff, Inc.1989-09-29
K880570DENVER PLEURO-PERITONEAL SHUNTCodman & Shurtleff, Inc.1988-06-20
K880401DENVER PERITONEO-VENOUS SHUNTCodman & Shurtleff, Inc.1988-05-31
K842139THE DENVER PLEURAL-PERITONEAL SHUNTDenver Biomedicals, Inc.1984-08-27
K822686DENVER PERITONEO-VENOUS SHUNT (DP-VS)Denver Biomedicals, Inc.1982-09-21