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2min
Posted by Zewski Ballpark Report
On Jan 8, 2025
Percutaneous Catheter
Device Type: Cardiovascular - Diagnostic
FDA Description:
A percutaneous catheter is a Class II medical device commonly used for therapeutic or diagnostic purposes. It is designed for minimally invasive access to the vascular or other bodily systems. The catheter is regulated under the FDA's Code of Federal Regulations (CFR) for medical devices. Most percutaneous catheters require FDA 510(k) clearance due to their intended use and potential risks, ensuring safety and effectiveness.
General Description:
A percutaneous catheter is a thin, flexible medical device used for accessing blood vessels, delivering medications, or facilitating drainage during minimally invasive procedures. This device is an essential tool in interventional medicine, including cardiology, oncology, and nephrology. It is inserted through the skin (percutaneous entry) and guided to the desired location using advanced imaging techniques.
Percutaneous catheters are typically made from biocompatible materials such as medical-grade plastics and silicone, ensuring flexibility, durability, and patient safety. These materials are often combined with radiopaque markers to enhance visibility during imaging. The device may be used as part of a system, connecting to external components such as syringes, infusion pumps, or monitoring devices.
The design prioritizes sterility, ease of use, and compatibility with various clinical settings. Depending on its intended use, the catheter may include additional features such as side ports, specialized coatings to reduce friction, or integrated guidewires for enhanced maneuverability. Due to its versatility and critical role in patient care, the percutaneous catheter is a staple in modern medical practice.
Percutaneous Catheter System
General Report
Project Overview
Cost & Time Estimates
Development Complexity
Technological Readiness
Regulatory Approval
Market Potential
Development Phases & Milestones
Resource Allocation & Team Involvement
Risk Mitigation Strategies
Investment & Financial Outlook
Feasibility
Understanding Your Feasibility Score
The Feasibility Score bar provides an assessment of your project’s path to market, with higher values indicating lower complexity and fewer anticipated obstacles.
- 0 - 39 (Low Feasibility): This range suggests that the project may face significant challenges due to high complexity or extensive requirements. Additional planning, resources, or risk mitigation strategies will be necessary.
- 40 - 74 (Moderate Feasibility): Projects within this range indicate a moderate path to market. While the overall complexity is manageable, some areas may require refinement or further development to ensure project stability and success.
- 75+ (High Feasibility): A score in this range indicates a relatively straightforward path to market, with low complexity and minimal additional work expected. This project is well-positioned to progress smoothly.
The Feasibility Score is a general guide, not an absolute measure of project success. We recommend using this score as part of a broader assessment and considering additional expert guidance for a comprehensive evaluation.
Cost & Time Breakdown
Phase I
Phase II
Phase III
Phase IV
Phase V
Disclaimers & Limitations
- Generalizations: This report provides a high-level overview based on standard assumptions and does not account for unique device characteristics. Actual costs, timelines, and risks may vary significantly depending on the device's design, use case, and target market.
- Assumptions of Device Class and Use: Assumptions were made regarding the device's classification and intended use. These assumptions can impact regulatory requirements, costs, and timelines. Specific regulatory pathways, for instance, may differ based on the device's risk classification and market entry strategy.
- Market and Regulatory Dynamics: Regulatory requirements and market conditions are subject to change. The report's cost and timeline estimates may be affected by evolving regulatory landscapes, standards, or unforeseen market dynamics, which could delay approval or require additional testing.
- Risk Assessment Limitations: Risk levels and mitigation strategies are based on general device categories and may not fully address specific technical or operational risks unique to the product. Thorough risk assessments should be tailored to the device's complexity, materials, and usage.
- Development Phases and Milestones: The development phases outlined here follow a typical medical device development pathway, but real-world project phases may overlap or require iteration due to unforeseen challenges or design changes.
- Cost and Timeline Variability: The cost and timeline estimates are based on standard industry benchmarks but do not account for project-specific adjustments. Factors like unexpected technical challenges, prototype iterations, or regulatory re-submissions can significantly impact final costs and schedules.
- Reliance on Industry Standards: The report relies on common industry standards for development and testing. However, additional standards specific to certain device features or regions may apply, affecting compliance requirements and associated timelines.
- Testing and Validation Scope: Testing and validation requirements are generalized. Devices with novel materials, complex electronics, or unique features may require additional, specialized tests, potentially extending both cost and duration.
- Supplier Chain for Complex Equipment: If your device includes advanced 'add-in' equipment like sensors, lasers, pumps, or vision systems, etc., the development timeline and associated costs will require a custom report.
