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510(k) K253671

Device
Dual Stage Venous Cannulae
Applicant
Sorin Group Italia S.R.L.
510(k) number
K253671
Product code
DWF
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-30
Date received
2025-11-21
Regulation
870.4210
Classification name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Luigi Vecchi
Address
Via Statale 12 Nord, 86 Mirandola IT 41037 41037

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DWF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.2026-04-23
K250937Venous Return CannulaeLivaNova USA, Inc.2026-03-11
K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors2026-02-23
K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.2026-02-19
K253998Clearview Intracoronary ShuntsMedtronic, Inc.2026-01-20
K253106AngioVac CannulaAngioDynamics, Inc.2025-10-24
K250283RAP Femoral Venous CannulaeLivaNova USA, Inc.2025-07-10
K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L.2025-06-27
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.2025-06-20
K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)Spectrum Medical S.R.L.2024-05-31
K240193R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)Sorin Group Italia S.R.L.2024-02-22
K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);Edwards Lifesciences2024-02-05
K231206DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc.2023-12-07
K230960DLP™ Silicone Coronary Artery Ostial CannulaeMedtronic, Inc.2023-05-04
K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VSQura S.R.L2022-08-18