The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edward Vent Catheters Edward Vent Catheters With Duraflo Coating Dispersion Aortic Perfusion Cannula.
| Device ID | K113411 |
| 510k Number | K113411 |
| Device Name: | EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA |
| 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 | Yes |
| Date Received | 2011-11-18 |
| Decision Date | 2012-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103147469 | K113411 | 000 |
| 00690103030907 | K113411 | 000 |
| 00690103030891 | K113411 | 000 |
| 00690103030884 | K113411 | 000 |