CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
FDA 510(k) clearance K141060 · decided 2014-06-06
Clearance details
- K-number
- K141060
- Device name
- CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
- Applicant
- On-X Life Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-24
- Decision date
- 2014-06-06
- Days to decision
- 43 days
- Clearance type
- Special
- Product code
- PAW
- Device class
- 2
- Regulation number
- 870.3470
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal re recall (Z-1057-2017) | On-X Life Technologies, Inc. | 2017-01-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| On-X Ascending Aortic Prosthesis (P000037/S067) | On-X Life Technologies, Inc. | 2025-12-17 |
| On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (AAP) (P000037/S066) | On-X Life Technologies, Inc. | 2025-10-22 |
| On-X Prosthetic Heart Valves; On-X Ascending Aortic Prothesis (P000037/S064) | On-X Life Technologies, Inc. | 2025-10-22 |
| On-X Heart Valve; On-X Ascending Aortic Prosthesis (P000037/S063) | On-X Life Technologies, Inc. | 2025-10-22 |
| On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (P000037/S065) | On-X Life Technologies, Inc. | 2025-10-22 |
| On-X Prosthetic Heart Valve (P000037/S062) | On-X Life Technologies, Inc. | 2024-03-05 |
| On-X Prosthetic Heart Valve and Ascending Aortic Prothesis (P000037/S061) | On-X Life Technologies, Inc. | 2023-11-08 |
| On- X Prosthetic Heart Valve, Ascending Aortic Prothesis (P000037/S060) | On-X Life Technologies, Inc. | 2022-08-01 |