The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Cardioplegia Delivery Sets Cardioplegia Delivery Sets With Duraflo Coating.
| Device ID | K113667 |
| 510k Number | K113667 |
| Device Name: | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Karen Jones |
| Correspondent | Karen Jones EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-13 |
| Decision Date | 2012-01-12 |
| Summary: | summary |