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Ultraverse RX PTA Balloon Dilatation Catheter

by Bard Peripheral Vascular, Inc. EUDAMED510(k)

Active European Union and United States

510(k) K131199Ref U8902H30

Overview

The Ultraverse RX PTA Balloon Dilatation Catheter is a catheter, angioplasty, peripheral, transluminal designed for percutaneous transluminal angioplasty (PTA). It is a rapid-exchange balloon catheter with a balloon fixed at the distal tip, intended for dilation of peripheral arteries, including renal, femoral, popliteal, and infra-popliteal vessels. The device features radiopaque markers to aid in precise balloon placement during procedures.

This catheter is supplied as a single-use, non-sterile device (sterilized prior to use) and is classified under FDA device class II. It is available in various sizes, including configurations such as 3 mm × 40 mm on a 4 French, 150 cm long catheter. The device has received FDA 510K clearance and MDR authorization, adhering to regulatory standards for peripheral vascular interventions. Storage and handling follow standard medical device protocols to ensure integrity before use.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741OVDRDUTB5M Basic UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK131199 Date30 May 2013ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

Trade Name
Ultraverse
Device Name
Ultraverse™ 014 & 018 PTA Balloon Dilatation Catheter
Model / Reference
U8902H30
Primary DI / UDI-DI
00801741165443
Basic UDI-DI
0801741OVDRDUTB5M
510(k) Number
FDA Product Code
LIT
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 870.1250
Market of Registration
Belgium
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

From the manufacturer

ULTRAVERSE ® RX PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the renal, femoral, popliteal and infra-popliteal arteries. This catheter is not for use in coronary arteries.

Source: bd.com

Ultraverse ™ RX PTA Dilatation Catheter 3 mm x 40 mm Balloon on 4 French, 150 cm long Catheter.

Source: bd.com

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Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No