Atlas FDA

CORDIS HAKIM ASCITES VALVE SYSTEM

FDA 510(k) clearance K803258 · decided 1981-01-15

Clearance details

K-number
K803258
Device name
CORDIS HAKIM ASCITES VALVE SYSTEM
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1980-12-23
Decision date
1981-01-15
Days to decision
23 days
Clearance type
Traditional
Product code
KPM
Device class
2
Regulation number
876.5955
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K012235)Denver Biomedical, Inc.2001-10-04
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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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086)Cordis Corp.2014-10-10
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082)Cordis Corp.2012-01-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085)Cordis Corp.2012-01-26
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059)Cordis Corp.2011-05-27
CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083)Cordis Corp.2011-05-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081)Cordis Corp.2011-03-03
CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026)Cordis Corp.2011-02-22
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078)Cordis Corp.2010-09-02