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Cardiopolmunary Bypass Cannula EasyFlow Aortic Cannula

by Sorin Group Italia SRL

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08033178019231 UDI-DI Date19 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Cardiopolmunary Bypass Cannula
Generic Name
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Model / Reference
EasyFlow Aortic Cannula
Primary DI / UDI-DI
08033178019231
510(k) Number
FDA Product Code
DWF
GMDN Term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Device Class
Class II
Regulation Number
870.4210
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250610)

Other devices from Sorin Group Italia SRL

See all devices from Sorin Group Italia SRL →

Properties

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

Other properties (9)

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