Atlas FDA

KPM

19 FDA 510(k) clearances · Product code

89 daysmedian time to decision
269 days90th percentile
19clearances measured

FDA profile

Official device name
Shunt, Peritoneal
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5955
Medical specialty
Gastroenterology, Urology
Flags
Implant
Adverse events (MAUDE)
2002: 2 · 2003: 3 · 2006: 2 · 2007: 2 · 2008: 3 · 2013: 68
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Automatic Continuous Effusion Shunt (ACES) System ACES System (K231096)Pleural Dynamics, Inc.2023-08-18
BD Curve Ascites Shunt (K170405)Care Fusion2017-11-02
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K012235)Denver Biomedical, Inc.2001-10-04
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT (K011862)Denver Biomedical, Inc.2001-07-12
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K011020)Denver Biomedicals, Inc.2001-06-01
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T (K003451)Denver Biomedicals, Inc.2001-01-02
DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS (K973129)Denver Biomaterials, Inc.1998-03-17
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K962814)Denver Biomaterials, Inc.1997-04-14
DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (K913728)Denver Biomedicals, Inc.1994-02-18
LEVEEN PERITINEO-VENOUS SHUNT (K901360)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-08-21
AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP (K894794)Vitaid, Ltd.1989-11-21
DENVER PERITONEO-VENUS SHUNT (K894756)Codman & Shurtleff, Inc.1989-09-29
DENVER PLEURO-PERITONEAL SHUNT (K880570)Codman & Shurtleff, Inc.1988-06-20
DENVER PERITONEO-VENOUS SHUNT (K880401)Codman & Shurtleff, Inc.1988-05-31
THE DENVER PLEURAL-PERITONEAL SHUNT (K842139)Denver Biomedicals, Inc.1984-08-27
DENVER PERITONEO-VENOUS SHUNT (DP-VS) (K822686)Denver Biomedicals, Inc.1982-09-21
DENVER PERITONEO-VENOUS SHUNT (K811183)Denver Biomedicals, Inc.1981-07-01
CORDIS HAKIM ASCITES VALVE SYSTEM (K803258)Cordis Corp.1981-01-15
VALVE, ASCITES, LAVEEN (K770602)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-04-15

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Every clearance here is in the API, with alerts when new ones post.