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 |