BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER by C.R. BARD, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER

Manufacturer

C.R. BARD, INC.

Date Cleared

2001-02-13

(26 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Summary

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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).