Identifiers
- 510(k) Number
- K252512 FDA 510(k)
- FDA Product Code
- LIT 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 Armada 14 NC PTA Catheter is a Catheter, Angioplasty, Peripheral, Transluminal designed for peripheral transluminal angioplasty (PTA). It is a non-compliant balloon catheter intended to dilate narrowed or occluded arteries, particularly in below-the-knee vasculature, to restore blood flow.
This device is supplied as a single-use, sterile catheter with radiopaque tungsten markers for precise positioning. It features a low crossing profile and low tip entry profile for improved deliverability. Authorized under FDA 510(k) clearance (K252512) as a Class II device under regulation 870.1250, it is intended for use in controlled clinical settings such as catheterization labs.
Frequently asked questions
What is the primary use of the Armada 14 NC PTA Catheter in clinical practice?
The Armada 14 NC PTA Catheter is specifically designed for peripheral transluminal angioplasty (PTA), a procedure to dilate narrowed or occluded arteries. It is particularly suited for below-the-knee vasculature, helping to restore blood flow in patients with peripheral arterial disease. Its non-compliant balloon structure ensures precise dilation of stenotic segments.
Is the Armada 14 NC PTA Catheter intended for single-use or reusable applications?
The device is explicitly supplied as a single-use catheter, meaning it is sterile upon packaging and intended for one-time clinical use only. This design minimizes infection risks and ensures consistent performance per regulatory standards.
How does the catheter’s design improve navigation through challenging vasculature?
The Armada 14 NC PTA Catheter features a low crossing profile and low tip entry profile, which enhance its deliverability through tortuous or narrow arteries. Additionally, it includes radiopaque tungsten markers for real-time fluoroscopic guidance, improving precision during positioning in complex anatomical regions like below-the-knee arteries.
What regulatory pathway was followed for FDA clearance of this device?
The Armada 14 NC PTA Catheter received FDA 510(k) clearance (K252512) under the traditional review process, classified as a Class II device under regulation 870.1250. It was determined to be substantially equivalent to a predicate device, with the Cardiovascular (CV) Advisory Committee overseeing the review. This clearance authorizes its use in controlled clinical settings like catheterization labs.
What storage or handling precautions should be taken with this catheter?
While the device data does not specify storage conditions, as a sterile, single-use catheter, it should be stored in its original packaging until use to maintain sterility. Avoid exposure to extreme temperatures, moisture, or contamination. Always follow manufacturer guidelines (e.g., Abbott Medical’s instructions) for optimal shelf life and handling to ensure device integrity.
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: Armada 14 and 14XT PTA Catheter | Abbott, Armada 14 NC PTA Catheter | Abbott, Armada™ 14 NC PTA Catheter (K252512) - FDA 510 (k), Armada™ 14 NC PTA Catheter 510 (k) K252512 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252512 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA 510(k) K252512 24 fields · synced Sep 19, 2026