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510(k) Data Aggregation
K Number
K971897Device Name
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
Manufacturer
Date Cleared
1997-10-21
(152 days)
Product Code
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
MEDRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the MEDRON CAVH Catheter is for accessing the vascular system for continuous arteriovenous hemofiltration.
Device Description
Catheter
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