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Aveir™ LSN25301

by St. Jude Medical, Inc.

Ref LSN25301

Aveir™ LSN25301 is a device classified as Class III in the EU and Class II in the US made by St. Jude Medical, Inc., registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 5415067LLD0006F7) with CE/MDR certificate G70 014607 0266 valid until 4 Jan 2032, cleared under FDA 510(k) K211989 on 27 Jul 2021 and listed in FDA GUDID since 14 Apr 2022 (UDI-DI 05415067034823), active as of 9 Nov 2026.

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

CE MDR 510(k)

Valid until

4 Jan 2032

CE MDR certificate

FDA recalls

None found

in data synced 9 Nov 2026

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

510(k) K211989

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberG70 014607 0266 Date5 Oct 2026IssuedStatusActive expires 4 Jan 2032
United StatesGUDID listing GUDID Number05415067034823 UDI-DI Date14 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK211989 Date27 Jul 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5415067LLD0006F7 registered 22 Sep 2026 Active· +1 more in the status table
  • FDA 510(k) K211989 decided 27 Jul 2021 Active
  • FDA GUDID UDI-DI 05415067034823 listed 14 Apr 2022 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 014607 0266 Active Reissued

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    5 Oct 2026
    Expires
    4 Jan 2032
    Valid from
    5 Jan 2027

Timeline

5 dated events

  1. Cleared FDA 510(k) K211989
  2. Listed FDA GUDID 05415067034823
  3. Registered EUDAMED 5415067LLD0006F7
  4. Certificate issued EUDAMED G70 014607 0266
  5. Certificate expires EUDAMED G70 014607 0266

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  • Withdrawn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 · GUDID

Trade name
Aveir™
Generic name
Vascular catheter introduction set, nonimplantable
Device name
Leadless Device Accessories-Introducers
Model / Ref / Catalog
LSN25301
Primary DI / UDI-DI
05415067034823
Basic UDI-DI
5415067LLD0006F7
510(k) Number
FDA product code
DYB
EMDN code
C0502 Cardiovascular introducer sheaths, valved
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1340
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 8.9000 Millimeter
Catheter Gauge — 25.0000 French
Length — 30.0000 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K211989)

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)