CHORD-X EPTFE SUTURE
FDA 510(k) clearance K121173 · decided 2012-08-16
Clearance details
- K-number
- K121173
- Device name
- CHORD-X EPTFE SUTURE
- Applicant
- On-Xlifetechnologies
- Decision
- Substantially Equivalent
- Date received
- 2012-04-17
- Decision date
- 2012-08-16
- Days to decision
- 121 days
- Clearance type
- Abbreviated
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MitraPatch Mitral Valve Repair System (K252126) | Chawla Heart Technologies, LLC | 2025-12-04 |
| CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT (K141060) | On-X Life Technologies, Inc. | 2014-06-06 |
Recalls involving this device
No recalls on record reference this clearance.