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510(k) Data Aggregation
K Number
K182570Device Name
Venture 0.014 Catheter
Manufacturer
Vascular Solutions, LLC
Date Cleared
2019-03-13
(176 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Vascular Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Venture 0.014" catheters are indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW version (Model 5821) may also be used for manual delivery of saline solution or diagnostic contrast agents.
Device Description
The Venture 0.014" catheters are single lumen catheters with a radiopaque deflectable distal tip designed to provide guidewire support during interventional procedures in the coronary and peripheral vasculature. The Venture 0.014" catheters are compatible with 0.014" guidewires and are available in two configurations. The rapid exchange configuration consists of a hypotube shaft with a rapid exchange (RX) lumen and deflectable tip on the distal segment. The over the wire configuration consists of an over-the-wire (OTW) lumen that runs the entire length of the catheter with a deflectable tip. The Venture 0.014" catheter tips are deflectable 90° by rotating a deflection knob on the control handle of the proximal end and a hydrophilic coating on the distal end of the catheter enhances deliverability to the target vasculature. The Venture 0.014" catheters are sterilized with ethylene oxide.
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