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Catheter, USCI Gruntzig/Balloon

FDA 510(k)

Class II (US FDA 510(k))

510(k) K782071

by C. R. Bard, Inc.

Identifiers

510(k) Number
K782071 FDA 510(k)
FDA Product Code
DYG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1240 FDA 510(k)
Regulation Number
870.1240 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Catheter, USCI Gruntzig/Balloon is a catheter, flow-directed, designed for vascular interventions. It incorporates a balloon mechanism to facilitate dilation of narrowed or obstructed blood vessels, commonly used in percutaneous transluminal angioplasty procedures. The device is intended for controlled expansion within coronary or peripheral arteries to restore lumen patency.

This catheter is supplied as a single-use, non-sterile device (sterilized prior to use) and is classified under FDA product code DYG as a Class II medical device. It is regulated under the FDA 510(k) clearance (K782071) and falls under the Cardiovascular specialty category. The device requires proper handling, including terminal sterilization by the user, and is intended for use in controlled clinical settings where vascular access and dilation are performed.

Frequently asked questions

What is the primary use of the USCI Gruntzig/Balloon Catheter?

The USCI Gruntzig/Balloon Catheter is designed specifically for vascular interventions, particularly to dilate narrowed or obstructed blood vessels during percutaneous transluminal angioplasty. It uses a built-in balloon mechanism to restore lumen patency in coronary or peripheral arteries, ensuring controlled expansion within the targeted vessel.

Is this catheter intended for single-use or repeated use?

This catheter is supplied as a single-use device. While it is non-sterile at the time of shipment, it is sterilized prior to use and requires terminal sterilization by the healthcare provider before clinical application. This ensures sterility and safety for each individual procedure.

How should the catheter be stored before use?

The catheter should be stored in its original packaging under clean, dry conditions, protected from direct sunlight and extreme temperatures. Since it requires terminal sterilization by the user, it is critical to follow the manufacturer’s instructions for sterilization (e.g., ethylene oxide or gamma irradiation) before use to maintain its integrity and safety.

What regulatory pathway does this device follow?

The USCI Gruntzig/Balloon Catheter is classified as a Class II medical device under FDA product code DYG and falls under the Cardiovascular specialty category. It was cleared via the FDA’s 510(k) pathway (K782071) and is regulated under the traditional review process, with a decision of substantial equivalence to a predicate device.

Can this catheter be used in both coronary and peripheral arteries?

Yes, the device is explicitly designed for use in both coronary and peripheral arteries. Its flow-directed design and balloon mechanism allow for controlled dilation of obstructed vessels in these critical vascular regions, making it versatile for a range of angioplasty procedures.

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: CATHETER, USCI GRUNTZIG/BALLOON (K782071) — FDA 510 (k) | Innolitics, Catheter, Usci Gruntzig/balloon 510(k) K782071 - FDA.report, PDF K782071 - Catheter, Usci Gruntzig/Balloon, USCI GRUNTZIG DILACA BALLOON DILATION (K830608) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K782071 24 fields · synced Oct 1, 2026