The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Suture Fastening System.
| Device ID | K150882 |
| 510k Number | K150882 |
| Device Name: | Edwards Suture Fastening System |
| Classification | Instrument, Ligature Passing And Knot Tying |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Nina Brooke |
| Correspondent | Nina Brooke EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | HCF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-02 |
| Decision Date | 2015-06-16 |
| Summary: | summary |