Atlas FDA

VALVE, ASCITES, LAVEEN

FDA 510(k) clearance K770602 · decided 1977-04-15

Clearance details

K-number
K770602
Device name
VALVE, ASCITES, LAVEEN
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1977-03-30
Decision date
1977-04-15
Days to decision
16 days
Clearance type
Traditional
Product code
KPM
Device class
2
Regulation number
876.5955
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Walker, MI, 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
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05