The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Anteplegia Catheter Antegrade Cardioplegia Catheter Aortic Root Cannula Antegrade Catheter With Duraflo Coating.
| Device ID | K113459 |
| 510k Number | K113459 |
| Device Name: | ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Dannette Crooms |
| Correspondent | Dannette Crooms EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-22 |
| Decision Date | 2012-06-29 |