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AVANTI™+ Catheter Sheath Introducer

by Cordis US Corp. 9 variants

Ref 402-606R

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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K932733↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), 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 10705032000604UDI-DIDate31 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number10705032000604 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK932733 Date26 Aug 1993IssuedStatusActive

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · 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
402-606R EUDAMED
402606R GUDID
Primary DI / UDI-DI
10705032000604
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
402-606R
GUDID
402606R
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