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510(k) K872221

Device
DIALY-NATE SET & DIALY-NATE CATHETER
Applicant
GESCO INTL., INC.
510(k) number
K872221
Product code
FKO  
Decision
Substantially Equivalent (SESE)
Decision date
1987-10-13
Date received
1987-06-09
Regulation
876.5630
Classification name
Catheter, Peritoneal Dialysis, Single Use
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GEORGE E SINKO
Address
P.O. Box 690188 San Antonio TX US 78269 78269

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FKO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964514CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSISCorpak, Inc.1998-06-26
K974570PERITONEAL DIALYSIS CATHETER CONNECTORMedigroup, Inc.1998-02-27
K910787TITANIUM CONNECTOR (2 PART)Accurate Surgical Instruments Co.1991-08-15
K885037AMUKIN 50% - AIRSPRAY(R)Bernard J. Cooney, P.A.1990-10-19
K874650PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)Quinton, Inc.1987-12-09
K871730MODIFIED USE OF PULL-APART INTRODUCER SETQuinton, Inc.1987-05-18
K870472ACUTE PERITONEAL DIALYSIS KITQuinton, Inc.1987-02-25
K860155PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8Medical Components, Inc.1986-02-14
K854966ACUTE PERITONEAL DIALYSIS CATHETERSThermedics, Inc.1986-01-09
K845041CAPD STAGED CONNECTORAbbott Laboratories1985-02-21
K813336LAZARUS-NELSON PERITONEAL LAVAGE TRAYAmerican Pharmaseal Div. Ahsc1981-12-18
K812717NON-STERILE SHADOW-STRIPE CATHETERQuinton, Inc.1981-10-19
K811266QUINTON CATHETER FINGER GRIPQuinton, Inc.1981-06-18
K802954DRESSING CHANGE TRAY-MEDIUMAssociated Medical Products Co.1980-12-17
K760544CATHETER, PERITONEAL DIALYSISTravenol Laboratories, S.A.1976-10-20

Legacy Summary#

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FDA Review#

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