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ViewFlex™ ICE-VF-SE-2D-01

by Irvine Biomedical, Inc.

Ref ICE-VF-SE-2D-01

ViewFlex™ ICE-VF-SE-2D-01 is a device classified as Class III in the EU and Class II in the US made by Irvine Biomedical, Inc., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 5414734DMS0012HS), cleared under FDA 510(k) K251231 on 20 May 2025 and listed in FDA GUDID since 21 Nov 2025 (UDI-DI 05415067053190), active as of 7 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251231

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734DMS0012HS Basic UDI-DI 05415067053190UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067053190 UDI-DI Date21 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK251231 Date20 May 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734DMS0012HS registered 24 Aug 2026 Active
  • FDA 510(k) K251231 decided 20 May 2025 Active
  • FDA GUDID UDI-DI 05415067053190 listed 21 Nov 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K251231
  2. Listed FDA GUDID 05415067053190
  3. Registered EUDAMED 5414734DMS0012HS

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  • Withdrawn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
ViewFlex™
Generic name
Intracardiac ultrasound imaging catheter, steerable, single-use
Device name
ViewFlex ICE Catheter
Model / Ref / Catalog
ICE-VF-SE-2D-01
Primary DI / UDI-DI
05415067053190
Basic UDI-DI
5414734DMS0012HS
510(k) Number
FDA product code
OBJ
EMDN code
C0104010102 Cardiac and intracoronary ultrasound catheters
GMDN term
Intracardiac ultrasound imaging catheter, steerable, single-use
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1200
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 9.0000 French
Length — 90.0000 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

Cleared under the same submission (K251231)

Similar devices in this category

Other devices filed under CARDIAC AND INTRACORONARY ULTRASOUND CATHETERS.

Other devices from Irvine Biomedical, Inc.(Ibi)

See all devices from Irvine Biomedical, Inc.(Ibi) →

Properties

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