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510(k) Data Aggregation
K Number
K223648Device Name
Cook® Spectrum® 2 MRC Central Venous Catheter
Manufacturer
Cook Advanced Technologies
Date Cleared
2023-02-03
(59 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Cook Advanced Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cook® Spectrum® 2 MRC Central Venous Catheter is indicated to provide short-term ( <30 days) central venous access intended for:
- Continuous or intermittent drug infusion
- · Central venous blood pressure monitoring (CVP)
- · Acute hyperalimentation
- · Blood sampling
- Delivery of whole blood or blood products
- · Simultaneous, separate infusion of drugs and
- · Power injection of contrast media (max 300 psi).
The activity of the antimicrobial agents, minocycline, rifampin and chlorhexidine is located at the internal and external catheter surfaces and is not intended for treatment of existing infections. This combination of antimicrobials has been shown to reduce microbial colonization of the catheter. The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained. Controlled studies of this product have not been conducted in pregnant women, pediatic or neomatal patients. The use of this catheter should be weighed against any possible risk. Consider CDC Guidelines and institutional protocols for catheter exchange.
Device Description
The Cook® Spectrum® 2 MRC Central Venous Catheter is a single-use, antibiotic impregnated, antimicrobial coated, power injectable catheter that is percutaneously inserted into the vasculature using the Seldinger technique, and advanced over a wire guide until its tip is positioned above the superior vena cava-right atrium (SVC-RA) junction within the lower third of the SVC. The Cook® Spectrum® 2 MRC Central Venous Catheter, 7 Fr triple lumen CVC, is made from an aliphatic polyether-based polyurethane catheter shaft with a radiopaque constituent and a bonded soft distal tip. The catheter shaft is impregnated with Spectrum® (minocycline, rifampin) antimicrobial agents and coated with chlorhexidine antiseptic. The Cook® Spectrum® 2 MRC Central Venous Catheter is not intended for treatment of existing infections in patients; the presence of the three antimicrobial agents has been shown to reduce microbial colonization of the catheter. The antimicrobial activity of these agents is localized to the internal and external catheter surfaces. The working length (15, 20, or 25 cm) of the catheter is measured from distal tip to the double bar line approximately 1.5 cm distal to the manifold. The catheter shaft features centimeter length markings. The proximal portion of the Cook® Spectrum® 2 MRC Central Venous Catheter, like the predicate catheter, has three extension tubes with injection-molded Luer hubs connected to a manifold. The injectionmolded manifold with suture wings serves as the transition point for lumens of the extension tubes into each lumen of the catheter shaft. All three lumens are power injectable; the maximum flow rate is labeled on the hub of each extension tube.
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