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510(k) Data Aggregation
K Number
K203409Device Name
MC3 Crescent Jugular Dual Lumen Catheter
Manufacturer
MC3, Inc.
Date Cleared
2021-05-03
(165 days)
Product Code
PZS
Regulation Number
870.4100Why did this record match?
Applicant Name (Manufacturer) :
MC3, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Device Description
The MC3 Jugular Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous (Seldinger type) vascular access methods. The introducer is designed to follow a prepositioned standard guide wire (not included) or obturator (blunt end closed tip introducer) when following a surgical placement. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length).
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