The following data is part of a premarket notification filed by On-x Life Technologies, Inc. with the FDA for Chord-x Pre-measured Loops For Mitral Chordal Replacement.
| Device ID | K141060 |
| 510k Number | K141060 |
| Device Name: | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT |
| Classification | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement |
| Applicant | ON-X LIFE TECHNOLOGIES, INC. 1300 East Anderson Lane Building B Austin, TX 78752 |
| Contact | John Ely |
| Correspondent | John Ely ON-X LIFE TECHNOLOGIES, INC. 1300 East Anderson Lane Building B Austin, TX 78752 |
| Product Code | PAW |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-24 |
| Decision Date | 2014-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813570020794 | K141060 | 000 |
| 00813570020510 | K141060 | 000 |
| 00813570020527 | K141060 | 000 |
| 00813570020534 | K141060 | 000 |
| 00813570020541 | K141060 | 000 |
| 00813570020558 | K141060 | 000 |
| 00813570020565 | K141060 | 000 |
| 00813570020572 | K141060 | 000 |
| 00813570020589 | K141060 | 000 |
| 00813570020503 | K141060 | 000 |
| 00813570020497 | K141060 | 000 |
| 00813570020015 | K141060 | 000 |
| 00813570020428 | K141060 | 000 |
| 00813570020435 | K141060 | 000 |
| 00813570020442 | K141060 | 000 |
| 00813570020459 | K141060 | 000 |
| 00813570020466 | K141060 | 000 |
| 00813570020473 | K141060 | 000 |
| 00813570020480 | K141060 | 000 |
| 00813570020596 | K141060 | 000 |
| 00813570020602 | K141060 | 000 |
| 00813570020718 | K141060 | 000 |
| 00813570020725 | K141060 | 000 |
| 00813570020732 | K141060 | 000 |
| 00813570020749 | K141060 | 000 |
| 00813570020756 | K141060 | 000 |
| 00813570020763 | K141060 | 000 |
| 00813570020770 | K141060 | 000 |
| 00813570020787 | K141060 | 000 |
| 00813570020701 | K141060 | 000 |
| 00813570020695 | K141060 | 000 |
| 00813570020619 | K141060 | 000 |
| 00813570020626 | K141060 | 000 |
| 00813570020633 | K141060 | 000 |
| 00813570020640 | K141060 | 000 |
| 00813570020657 | K141060 | 000 |
| 00813570020664 | K141060 | 000 |
| 00813570020671 | K141060 | 000 |
| 00813570020688 | K141060 | 000 |
| 00813570020404 | K141060 | 000 |