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Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Line Extension

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121856

by C. R. Bard, Inc.

Identifiers

510(k) Number
K121856 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 Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Line Extension are over-the-wire catheters used for Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters feature semi-compliant, low-profile balloons with two radiopaque marker bands for placement visualization and are compatible with 0.014" and 0.018" guidewires.

The catheters are supplied as single-use devices and should be used under high quality fluoroscopic observation to confirm balloon location. They are not for use in coronary arteries. The device has received FDA 510(k) clearance with the product code LIT and is classified as Class II under regulation number 870.1250.

Frequently asked questions

What are the Ultraverse 014 and 018 PTA Balloon Dilatation Catheters used for?

These catheters are designed for Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. They feature semi-compliant, low-profile balloons with two radiopaque marker bands for placement visualization.

Are these catheters single-use or reusable?

The Ultraverse 014 and 018 PTA Balloon Dilatation Catheters are supplied as single-use devices and should not be reused. They must be used under high quality fluoroscopic observation to confirm balloon location.

What guidewire sizes are compatible with these catheters?

These catheters are compatible with both 0.014" and 0.018" guidewires, making them versatile for different clinical procedures involving peripheral arteries.

What is the regulatory classification of these catheters?

The device has received FDA 510(k) clearance with the product code LIT and is classified as Class II under regulation number 870.1250. It is not for use in coronary arteries.

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: Ultraverse™ 018 PTA Dilatation Catheters - BD, Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension, Ultraverse 014 and 018 Balloon Dilatation Catheters (K093965) — Fda 510 ...

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) K121856 24 fields · synced Oct 6, 2026