Skip to content

Dorado™ PTA Balloon Dilatation Catheter

by Bard Peripheral Vascular, Inc.

510(k) K250219Ref DR4044

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250219↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741WBRJBRDJYP Basic UDI-DI 00801741058295UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250219 Date17 Jun 2025ClearedStatusActive
United StatesGUDID listing GUDID Number00801741058295 UDI-DI Date8 Aug 2016ListedStatusListed GUDID: in commercial distribution

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 found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Dorado EUDAMED
Dorado® GUDID
Generic Name
Peripheral angioplasty balloon catheter, basic
Model / Ref / Catalog
DR4044
Primary DI / UDI-DI
00801741058295
Basic UDI-DI
0801741WBRJBRDJYP
510(k) Number
FDA Product Code
DQY, LIT
EMDN Code
C010402020101 PTA balloon dilatation catheters
GMDN Term
Peripheral angioplasty balloon catheter, basic
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.1250
EU market of registration
Belgium
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

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

Other devices from Bard Peripheral Vascular, Inc.

See all devices from Bard Peripheral Vascular, Inc. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No