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510(k) Data Aggregation
K Number
K062112Device Name
SUNMED FOLEY CATHETERS
Manufacturer
SUNMED, INC.
Date Cleared
2007-06-04
(315 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
SUNMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SunMed Foley Catheter is used to drain fluids to and from the urinary tract.
Device Description
The catheters are comprised of a 2 lumen shaft with proximal funnel, inflation valve and distal retaining balloon. One lumen is for draining fuleds to and from the urinary tract. The second lumen is to inflate and deflate the balloon. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. The balloon fill volumes in ml and shaft size in French Gauge (Fr), Charriere (Ch) or millimeter (mm) are indicated on the funnel of each individual cathter and the distal tip type can be indicated on the individual pack label and / or outer carton. Sizes range from 6 to 30 Ch / Fr.
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K Number
K955631Device Name
ORTHOPLUG HARD BONE DESIGN
Manufacturer
SUNMED, INC.
Date Cleared
1996-02-27
(78 days)
Product Code
LZN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SUNMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955632Device Name
ORTHOPLUG SOFT BONE DESIGN
Manufacturer
SUNMED, INC.
Date Cleared
1996-02-27
(78 days)
Product Code
LZN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SUNMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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