Shunt, Peritoneal
Gastroenterology, Urology · 21 CFR 876.5955
Recent MDR events
126 adverse event reports on file
- SHUNT PAK, 11.5FR DOUBLE-VALVEJul 30, 2025InjuryCarefusion, Inc1625685-2025-00076
- SHUNT PAK, 11.5FR DOUBLE-VALVEJul 23, 2024InjuryCarefusion, Inc1625685-2024-00086
- SHUNT PAK, 11.5FR DOUBLE-VALVEJun 6, 2024InjuryCarefusion, Inc1625685-2024-00059
- SHUNT PAK, 11.5FR DOUBLE-VALVEMay 10, 2024MalfunctionCarefusion, Inc1625685-2024-00048
- SHUNT PAK, 11.5FR DOUBLE-VALVEApr 30, 2024InjuryCarefusion, Inc1625685-2024-00045
- SHUNT PAK, 11.5FR DOUBLE-VALVESep 29, 2023InjuryCarefusion, Inc1625685-2023-00097
- SHUNT PAK, 11.5FR DOUBLE-VALVEJun 22, 2022MalfunctionCarefusion, Inc1625685-2022-00066
- SHUNT PAK, 11.5FR DOUBLE-VALVEMay 10, 2022MalfunctionCarefusion, Inc1625685-2022-00049
- SHUNT DENVER ASCITES DOUBLE VALVEDec 18, 2017MalfunctionCarefusion, Inc1625685-2017-00422
- DENVER SHUNTSMay 4, 2017DeathCarefusion, Inc1625685-2017-00288
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
12 firms currently registered for this product code
510(k) clearances
19 clearances for this product code
- Pleural Dynamics, Inc.Aug 18, 2023
K231096 · Automatic Continuous Effusion Shunt (ACES) System ACES System
- Care FusionNov 2, 2017
K170405 · BD Curve Ascites Shunt
- Denver Biomedical, Inc.Oct 4, 2001
K012235 · DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- Denver Biomedical, Inc.Jul 12, 2001
K011862 · DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
- Denver Biomedicals, Inc.Jun 1, 2001
K011020 · DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- Denver Biomedicals, Inc.Jan 2, 2001
K003451 · DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
- Denver Biomaterials, Inc.Mar 17, 1998
K973129 · DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
- Denver Biomaterials, Inc.Apr 14, 1997
K962814 · DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER