Search Results
Found 3 results
510(k) Data Aggregation
K Number
K130441Device Name
FALLER STYLET
Manufacturer
MEDIONICS INTERNATIONAL, INC.
Date Cleared
2013-04-19
(57 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
MEDIONICS INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Faller stylet is a surgical tool used to create a subcutaneous tunnel for a peritoneal dialysis catheter, from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.
Device Description
Faller Stylet
Ask a Question
K Number
K993149Device Name
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
Manufacturer
MEDIONICS INTERNATIONAL, INC.
Date Cleared
2000-04-28
(220 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
MEDIONICS INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Peritoneal Dialysis Catheters and Adapters are access devices used for providing peritoneal dialysis treatment for patients suffering from End Stage Renal Disease (ESRD). Their main function is to allow the bi-directional flow of peritoneal dialysis solution in a consistent manner, without requiring extraordinary effort or causing discomfort.
Device Description
Not Found
Ask a Question
K Number
K994218Device Name
EASY CARE AND TUBING SETS
Manufacturer
MEDIONICS INTERNATIONAL, INC.
Date Cleared
2000-02-10
(57 days)
Product Code
FKX
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
MEDIONICS INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Easy Care and Tubing Sets are used to provide peritoneal dialysis fluid exchanges for patients suffering from End Stage Renal Disease (ESRD). Their main function is to allow the bi-directional flow of peritoneal dialysis solution in and out of the peritoneal cavity of the patient by means of gravity.
Device Description
Not Found
Ask a Question
Page 1 of 1