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510(k) Data Aggregation
K Number
K101599Device Name
RVT CTO DEVICE
Manufacturer
REVASCULAR THERAPEUTICS, INC.
Date Cleared
2011-01-18
(225 days)
Product Code
PDU
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
REVASCULAR THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RVT CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.
The RVT Extension Wire is designed to extend the RVT CTO Device so that a catheter can be exchanged for another catheter.
Device Description
The RVT CTO Device is a sterile, disposable, steerable 0.018" OD Guidewire with an Active Tip for penetrating chronic total occlusions and is used with a sterile, disposable, battery-operated Control Unit during a single patient procedure.
The RVT CTO System consists of four (4) components: the RVT CTO Device, Control Unit, Shaping Tool, and the RVT Extension Wire.
1. RVT CTO Device (Guidewire Assembly, Torquer, Motor Housing with integrated Connector Cable) - The RVT CTO Device consists of a distal 0.018" Guidewire Assembly and a Motor Housing with Connector Cable. The RVT CTO Device is 165 cm in working length and is hydrophilically coated. The RVT CTO Device has a shapeable Distal Tip and the cone-shaped portion of the Active Tip is diamond coated. The distal 3 cm is radiopaque to facilitate visualization under fluoroscopy.
2. Control Unit - Pressing the Activation Button allows current to flow from the battery in the Control Unit to the DC Motor within the Motor Housing. Mechanical energy (via rotational torque) is generated and transferred from the DC Motor to the Nitinol Driveshaft located within the stationary hollow Outer Shaft. The Driveshaft turns the Active Tip at the very distal end of the Guidewire Assembly at approximately 13,000 revolutions per minute (RPM) under "no load" conditions. The hollow Outer Shaft remains stationary while the Active Tip rotates independently. In the Active Mode, the RVT Guidewire creates a pathway through the lesion via mechanical rotation. In the "Passive Mode" the operator steers the Guidewire Assembly to seek a path of least resistance through the lesion consistent with standard quidewires.
3. Shaping Tool used to shape the tip of the RVT CTO Device, if desired.
4. RVT Extension Wire Attachment of the RVT Extension Wire to the RVT CTO Device creates an extended guidewire that can be used to exchange a catheter without removing the RVT CTO Device from the artery.
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