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510(k) Data Aggregation
K Number
K032710Device Name
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
Manufacturer
APOGEE MEDICAL, INC.
Date Cleared
2004-01-09
(129 days)
Product Code
KOD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
APOGEE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apogee Closed System Intermittent Catheterization Kit is intended to be used to drain urine from the patient's bladder into a collection bag.
Device Description
The Apogee Closed System Intermittent Catheterization Kit is a single-use, disposable, pre-lubricated catheter contained in a sterile collection bag. The Closed System Intermittent Catheter is intended to be user to drain urine from the bladder. When it is not practical or feasible for the patient to drain the bladder into a commode or bedpan, the urine may be drained into the collection bag of the Closed System Intermittent Catheterization Kit. The Closed System Intermittent Catheterization Kit is designed with a collection bag and introducer which provide the mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter, thereby, reducing possibility of contamination.
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K Number
K011552Device Name
UROLOGICAL CATHETER
Manufacturer
APOGEE MEDICAL, INC.
Date Cleared
2001-07-18
(61 days)
Product Code
GBM
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
APOGEE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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