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510(k) Data Aggregation
K Number
K073520Device Name
ANGIOTECH CVC
Manufacturer
Date Cleared
2008-04-11
(119 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
ANGIOTECH PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The multiple-lumen catheter permits venous access to the central circulation. The Angiotech antimicrobial surface is intended to help provide protection against bacterial colonization on the catheter surface and it may help reduce catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for longer than 30 days use.
Device Description
The Angiotech® CVC Multi-lumen Central Venous Catheter with MEDI-COATTM Antimicrobial Surface is a 7-French, polyurethane triple lumen, 15 or 20-cm catheter with a MEDI-COAT containing 48.8 µg/cm of 5-fluorouracil.
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