Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241370 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 Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) is a steerable sheath system designed for flexible catheter positioning in cardiac anatomy. It features a bi-directional steerable introducer, dilator, and guidewire to facilitate precise navigation within the vascular system. This device is classified as a cardiovascular introducer sheath, enabling enhanced access and stability for interventional procedures. Its dual-reach configuration accommodates larger catheter sizes, expanding procedural versatility.
The device is supplied as a single-use, sterile medical instrument intended for use in cardiac catheterization laboratories. It is compatible with MRI environments, though specific safety guidelines must be followed. The I-V2-MED model is part of a 13 Fr (French) catheter system, with dimensions and specifications detailed in the accompanying instructions for use. Regulatory clearance under FDA 510(k) (K241370) confirms its compliance with U.S. medical device standards, ensuring adherence to safety and performance requirements.
Frequently asked questions
What is the Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) used for?
The Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) is designed for flexible catheter positioning in cardiac anatomy. Its bi-directional steerable introducer, dilator, and guidewire enable precise navigation within the vascular system, improving stability and access during interventional procedures. The dual-reach configuration also accommodates larger catheter sizes, increasing procedural versatility in cardiac catheterization labs.
How is the Agilis NxT Dual-Reach (I-V2-MED) supplied and intended for use?
This device is supplied as a single-use, sterile medical instrument. It is intended exclusively for use in cardiac catheterization laboratories to facilitate precise catheter placement. The sterility ensures patient safety, and the single-use nature reduces the risk of cross-contamination between procedures.
Is the Agilis NxT Dual-Reach (I-V2-MED) compatible with MRI environments?
Yes, the Agilis NxT Dual-Reach (I-V2-MED) is compatible with MRI environments, though specific safety guidelines must be followed during use. Compatibility with MRI allows for integration into imaging-guided procedures, enhancing procedural accuracy and reducing the need for additional imaging sessions.
What size catheter system does the I-V2-MED model belong to, and what are its dimensions?
The I-V2-MED model is part of a 13 Fr (French) catheter system. Detailed dimensions and specifications are provided in the accompanying instructions for use. The 13 Fr size is designed to accommodate larger catheters, offering flexibility for various interventional techniques in cardiac procedures.
What regulatory clearance does the Agilis NxT Dual-Reach (I-V2-MED) have?
The Agilis NxT Dual-Reach (I-V2-MED) holds FDA 510(k) clearance under the reference number K241370. This clearance confirms its substantial equivalence to a predicate device and ensures compliance with U.S. medical device standards for safety and performance. The device was reviewed by the FDA’s Cardiovascular Advisory Committee.
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: About the Agilis NxT Steerable Introducer | Abbott, Agilis NxT Steerable Introducer Indications, Safety and Warnings | Abbott, PDF Instructions for Use Reprocessed Agilis NxT Steerable Introducer, Agilis NxT Steerable Introducer - Abbott Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241370 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA 510(k) K241370 24 fields · synced Oct 1, 2026