Intravascular Introducer System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063658 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Intravascular Introducer System is a catheter introducer (product code DYB) designed for percutaneous vascular access. It provides a controlled pathway for the insertion and removal of vascular catheters, facilitating procedures such as embolization. Constructed as a sterile, single-use device, it minimizes infection risk and ensures patient safety during interventions. Its design aligns with Class II regulatory standards under special controls, ensuring compliance with cardiovascular device requirements.
This system is intended for use in clinical settings requiring vascular access, including interventional radiology and cardiology. Supplied in a sterile, single-use configuration, it must be handled under aseptic conditions and discarded after one use. The device is not MRI-compatible and must be stored in its original packaging until deployment. Authorized under FDA 510(k) clearance (K063658), it adheres to cardiovascular advisory committee guidelines and is classified under product code DYB for introducers and catheters.
Frequently asked questions
What is the Intravascular Introducer System designed for?
The Intravascular Introducer System is specifically designed for percutaneous vascular access, providing a controlled pathway for inserting and removing vascular catheters. This is particularly useful in procedures like embolization, where precise access is critical. Its design ensures minimal trauma to the vessel wall while maintaining stability for subsequent catheter manipulation.
How is the Intravascular Introducer System supplied and should it be reused?
The system is supplied in a sterile, single-use configuration to prevent infection and ensure patient safety. It must be handled under aseptic conditions and discarded after one use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and increase infection risks.
Is the Intravascular Introducer System compatible with MRI and how should it be stored?
No, the Intravascular Introducer System is not MRI-compatible, so it should never be used in an MRI environment. For storage, it must remain in its original packaging until ready for deployment to maintain sterility and integrity. Avoid exposure to moisture, extreme temperatures, or direct sunlight.
What regulatory approval does the Intravascular Introducer System hold?
The device holds FDA 510(k) clearance under the reference number K063658, classified under product code DYB for introducers and catheters. It adheres to Class II regulatory standards with special controls, aligning with cardiovascular device requirements and guidelines from the Cardiovascular Advisory Committee.
Can this system be used in any clinical setting requiring vascular access?
Yes, the Intravascular Introducer System is intended for clinical settings that require vascular access, including interventional radiology and cardiology. Its design supports controlled access during procedures like embolization, where precise catheter placement is essential. Always follow manufacturer instructions and local clinical protocols for optimal use.
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: K063658 FDA 510 (k) - INTRAVASCULAR INTRODUCER SYSTEM, INTRAVASCULAR INTRODUCER SYSTEM (K063658) — FDA 510 (k) | Innolitics, Intravascular Introducer System - Applied Medical Resources | FDA ..., K041506 FDA 510(k) - INTRAVASCULAR ACCESS INTRODUCER SHEATH
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063658 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA 510(k) K063658 24 fields · synced Oct 1, 2026