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KPM — Shunt, Peritoneal Class II

FDA Device Classification

Classification Details

Product Code
KPM
Device Class
Class II
Regulation Number
876.5955
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231096pleural dynamicsAutomatic Continuous Effusion Shunt (ACES) System ACES SystemAugust 18, 2023
K170405care fusionBD Curve Ascites ShuntNovember 2, 2017
K012235denver biomedicalDENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUOctober 4, 2001
K011862denver biomedicalDENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNTJuly 12, 2001
K011020denver biomedicalsDENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERJune 1, 2001
K003451denver biomedicalsDENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUJanuary 2, 2001
K973129denver biomaterialsDENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITSMarch 17, 1998
K962814denver biomaterialsDENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERApril 14, 1997
K913728denver biomedicalsDENVER(R) PERITONEO-SUBCLAVIAN SHUNTFebruary 18, 1994
K901360bd becton dickinson vacutainer systems preanalyticLEVEEN PERITINEO-VENOUS SHUNTAugust 21, 1990
K894794vitaidAGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMPNovember 21, 1989
K894756codman and shurtleffDENVER PERITONEO-VENUS SHUNTSeptember 29, 1989
K880570codman and shurtleffDENVER PLEURO-PERITONEAL SHUNTJune 20, 1988
K880401codman and shurtleffDENVER PERITONEO-VENOUS SHUNTMay 31, 1988
K842139denver biomedicalsTHE DENVER PLEURAL-PERITONEAL SHUNTAugust 27, 1984
K822686denver biomedicalsDENVER PERITONEO-VENOUS SHUNT (DP-VS)September 21, 1982
K811183denver biomedicalsDENVER PERITONEO-VENOUS SHUNTJuly 1, 1981
K803258cordisCORDIS HAKIM ASCITES VALVE SYSTEMJanuary 15, 1981
K770602bd becton dickinson vacutainer systems preanalyticVALVE, ASCITES, LAVEENApril 15, 1977