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014 Hydrophilic Coated PTA Balloon Dilatation Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171251

by Creagh Medical

Identifiers

510(k) Number
K171251 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)

This device is a Catheter, Angioplasty, Peripheral, Transluminal designed for Percutaneous Transluminal Angioplasty (PTA). It is used to dilate stenoses in peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, as well as obstructive lesions in native or synthetic arteriovenous dialysis fistulae. The hydrophilic coating facilitates smooth insertion and navigation through vascular pathways.

The catheter is supplied as a single-use device and is intended for use in interventional radiology and cardiology settings. It is classified as a Class II medical device under FDA regulations (870.1250) and has received FDA 510K clearance (K171251) as substantially equivalent. No specific MRI safety information is provided, and it is not intended for reusable applications. Storage conditions are not detailed in the specifications.

Frequently asked questions

What types of vascular blockages can this balloon catheter treat, and where in the body is it primarily used?

This 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is designed to treat stenoses (narrowing) in peripheral blood vessels, including the iliac, femoral, ilio-femoral, popliteal, infrapopliteal arteries, and renal arteries. It is also used for obstructive lesions in native or synthetic arteriovenous dialysis fistulae. The hydrophilic coating helps ensure smooth navigation through these vascular pathways during Percutaneous Transluminal Angioplasty (PTA).

Is this device intended for reuse, or is it meant to be used only once?

This device is explicitly labeled as a single-use catheter. It is not designed or cleared for reuse, so each unit should be discarded after one procedure to maintain safety and sterility.

What special features does the hydrophilic coating provide during use?

The hydrophilic coating on this catheter reduces friction, making it easier to insert and navigate through the vascular system. This helps improve maneuverability, especially in tortuous or narrow blood vessels, while minimizing trauma to the vessel walls during angioplasty.

Are there any specific storage instructions provided for this device?

The provided data does not include explicit storage conditions for this catheter. However, as a single-use medical device, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures until use. Always follow manufacturer guidelines if additional storage instructions are available.

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: Advance Serenity® 14 Hydrophilic PTA Balloon Dilatation Catheter, 014 Hydrophilic Coated PTA Balloon Dilatation Catheter (K171251) — FDA ..., SABER .014 PTA Dilatation Catheter - Cordis, Highlander™ 014 PTA Balloon Dilatation Catheter - H415044 | BD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Creagh Medical

Sources (1)

  • FDA 510(k) K171251 24 fields · synced Sep 19, 2026