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510(k) Data Aggregation
K Number
K143102Device Name
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex Inc.)
Date Cleared
2015-07-24
(268 days)
Product Code
NIE
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
Arrow International, Inc. (Subsidiary of Teleflex Inc.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, apheresis, rapid fluid administration, intravenous therapy, blood sampling, pressure injection of contrast media, and central venous pressure monitoring. The catheter may also be used in a variety of renal replacement therapies, such as hemofiltration and hemoperfusion. The catheter may be inserted into the jugular, subclavian, or femoral veins. The maximum pressure injection flow rate is 6 mL / sec.
Device Description
The Multi-Lumen Acute Hemodialysis Catheter for High Volume (hereafter referred to as the 3-L AHDC) is a short-term, single use catheter designed to provide access to the central venous system in a healthcare facility environment. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in a 12 Fr. triple-lumen configuration with usable lengths of 16-25 cm. The catheters can be used for the injection of contrast media. The maximum recommended pressure injection flow rate is 6 mL/sec.
The catheters are packaged sterile with various components to facilitate insertion.
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