Identifiers
- 510(k) Number
- K171335 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Venture 038 Catheter is a deflectable, over-the-wire, single-lumen catheter designed for vascular access and navigation. Its radiopaque distal tip enables real-time fluoroscopic visualization, facilitating precise placement within peripheral blood vessels. The device is intended for use with guidewires of 0.035" or 0.038" diameter, allowing physicians to steer and manipulate the catheter within complex vascular anatomy. This classification aligns with FDA product code DQY, which categorizes it as a cardiovascular device.
The Venture 038 Catheter is supplied as a single-use, sterile device and is intended for use in clinical settings such as catheterization labs or interventional radiology. It is regulated under FDA 510(k) clearance (K171335), granted through the Special 510(k) pathway following a 30-day review by the Cardiovascular (CV) Advisory Committee. No additional regulatory status beyond the stated clearance is implied. The device’s design enables manual deflection of the distal tip, aiding in the navigation of tortuous vasculature during procedures.
Frequently asked questions
What is the Venture 038 catheter designed for?
The Venture 038 catheter is specifically designed for vascular access and navigation in clinical settings like catheterization labs or interventional radiology. Its deflectable distal tip allows physicians to steer and manipulate the catheter through tortuous or complex blood vessels, ensuring precise placement. The radiopaque tip also enables real-time visualization under fluoroscopy, which is critical for accurate procedural guidance.
How is the Venture 038 catheter supplied, and is it reusable?
The Venture 038 catheter is supplied as a single-use, sterile device. It is not intended for reuse, as single-use medical devices are designed for one-time clinical application to maintain sterility, safety, and compliance with regulatory standards. This ensures consistent performance and reduces the risk of contamination or device degradation between procedures.
What guidewire sizes is the Venture 038 catheter compatible with?
The Venture 038 catheter is compatible with guidewires of either 0.035” or 0.038” diameter. This flexibility allows clinicians to use the catheter with their preferred guidewire size, depending on the specific procedural requirements or patient anatomy. The over-the-wire design ensures compatibility with these standard guidewire diameters.
How does the deflectable tip of the Venture 038 catheter improve procedural navigation?
The deflectable distal tip of the Venture 038 catheter enables manual steering, which is particularly useful in navigating tortuous or challenging vascular pathways. This feature allows physicians to position the catheter more precisely within the blood vessels, reducing the risk of misplacement or trauma. Combined with real-time fluoroscopic visualization, it enhances procedural control and success.
What regulatory pathway was followed for the Venture 038 catheter’s clearance?
The Venture 038 catheter received FDA clearance through the Special 510(k) pathway, which involves a 30-day review by the Cardiovascular (CV) Advisory Committee. The device was determined to be substantially equivalent to a legally marketed predicate under product code DQY, which classifies it as a cardiovascular device. This pathway ensures a streamlined yet thorough evaluation process for innovative medical devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Venture 038 Catheter - Vascular Solutions | FDA Evidence Review, Venture 038 catheter (K171335) — FDA 510 (k) | Innolitics, K171335 FDA 510 (k) - Venture 038 catheter, Venture® 038 catheter M20658230 Medical Device Identification
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171335 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA 510(k) K171335 24 fields · synced Oct 1, 2026