The following data is part of a premarket notification filed by Edwards Lifesciences Llc. with the FDA for Edwards Lifesciences Thruport Knotting System.
| Device ID | K141206 |
| 510k Number | K141206 |
| Device Name: | EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | EDWARDS LIFESCIENCES LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Nina Brooke |
| Correspondent | Nina Brooke EDWARDS LIFESCIENCES LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-09 |
| Decision Date | 2015-01-16 |
| Summary: | summary |