Skip to content

AVANTI™+ Catheter Sheath Introducer

by Cordis US Corp. 9 variants

Ref 504-604P

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07050320000000000000010C4 Basic UDI-DI 10705032009904UDI-DIDate31 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number10705032009904 UDI-DI Date1 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

2 recalls · FDA

    • Terminated Z-2079-2021 FDA Class II initiated 9 Jun 2021

    The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

    • Terminated Z-1174-2016 FDA Class II initiated 31 Dec 2015

    Incorrect cannula of the sheath introducer (smaller than intended).

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
AVANTI™+ Catheter Sheath Introducer EUDAMED
Avanti GUDID
Generic Name
Haemostasis valve
Device Name
Catheter Sheath Introducer - AVANTI™+ Catheter Sheath Introducer
Model / Ref / Catalog
504-604P EUDAMED
504604P GUDID
Primary DI / UDI-DI
10705032009904
Basic UDI-DI
07050320000000000000010C4
510(k) Number
FDA Product Code
DRE
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Haemostasis valve
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1310
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
504-604P
GUDID
504604P
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000020031
Authorised representative
Cordis Cashel IE-AR-000017793

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

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

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No