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Catheter Guide Wire
Device Type: Cardiovascular - Diagnostic
FDA Description:
A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
Premarket Notification: Not Exempt
Eligible for Third Party Review: Yes
The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process, in which accredited Third Party Review Organizations are allowed to review certain low-to-moderate risk medical devices. The program is intended to help yield more rapid 510(k) decisions and to allow the FDA to focus its resources on higher risk devices, while still maintaining oversight of the review of lower risk devices eligible for third party review.
510(k) Associated with Regulation No. 870.1240 | DQX - Wire, Guide, Catheter
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K232578: Vassallo GT 018 G12; Vassallo GT 018 G30
K232574: Vassallo GT Crossing14
K231954: Aristotle 18 Guidewire; Aristotle 24 Guidewire
Custom Reports include detailed visual and interactive tools:
Feasibility Score: The Feasibility Score, or Zewski Score, is a number between 1-100 that identifies how difficult of a program your project is to initiate and maintain a plan and budget for relative to other projects on the scale. The higher the risk of the project, the lower the score. Average Class II projects fall between 40 and 60. Projects above 75 are generally straightforward. Those below 25 are complex and extremely high risk.
Compliance Score: Similar to the Feasibility Score, the Compliance Score runs between 1 and 100. However, this score only looks at the difficulty of the FDA approval process. Its values focus more on patient risk and testing challenges than business feasibility. Your Compliance Score may differ depending on the overall project details. For example, a project with a small market but little risk will have a lower Feasibility Score than Compliance Score.
Indications Assessment: Detailed breakdown of the typical indications for product code BZE and the impact on risk, cost, and time related to the development and delivery of this project.
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Financial Assessment: Includes cost scenarios based on the manufacturing process and location, with the necessary quality level for each aspect of your project. It will also look at low- and high-volume scenarios plus any needed labor and automation to assess possible cost efficiencies.