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510(k) Data Aggregation
K Number
K141818Device Name
TURBO-JECT PICC SETS
Manufacturer
Date Cleared
2014-08-05
(29 days)
Product Code
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
COOK CORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.
Device Description
The 3.0, 4.0, 5.0, and 6.0 Fr Turbo-Ject PICC Sets with various lumen configurations are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer or over-the-wire. The set components may include the PICC, obturator, Peel-Away introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.
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