The following data is part of a premarket notification filed by On-xlifetechnologies with the FDA for Chord-x Eptfe Suture.
| Device ID | K121173 |
| 510k Number | K121173 |
| Device Name: | CHORD-X EPTFE SUTURE |
| Classification | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement |
| Applicant | ON-XLIFETECHNOLOGIES 1300 EAST ANDERSON LANE BLDG B Austin, TX 78752 |
| Contact | John Ely |
| Correspondent | John Ely ON-XLIFETECHNOLOGIES 1300 EAST ANDERSON LANE BLDG B Austin, TX 78752 |
| Product Code | PAW |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-17 |
| Decision Date | 2012-08-16 |
| Summary: | summary |