Device type
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Product code DWF · Class II · 21 CFR 870.4210 · Cardiovascular
Recent 510(k)s
Oct 30, 2026
K263076
AngioVac F1885
AngioDynamics, Inc.
- DWF
- Class II
Oct 29, 2026
K263596
DLP™ Coronary Ostial Cannulae
Medtronic, Inc.
- DWF
- Class II
Oct 1, 2026
K263092
Dual Stage Venous Cannulae
Sorin Group Italia S.R.L.
- DWF
- Class II
Sep 28, 2026
K262052
Tri Stage Venous Cannulae
Sorin Group Italia S.R.L.
- DWF
- Class II
Recent recalls
Sep 23, 2026
Z-3144-2026
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Maquet Cardiopulmonary Gmbh
- DWF
- Class II
- Ongoing
Sep 23, 2026
Z-3145-2026
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Maquet Cardiopulmonary Gmbh
- DWF
- Class II
- Ongoing
Sep 23, 2026
Z-3146-2026
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Maquet Cardiopulmonary Gmbh
- DWF
- Class II
- Ongoing