510(k) K141060
K141060 is an FDA 510(k) premarket notification submitted by On-X Life Technologies, Inc. for the device "CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT". The FDA issued a decision of Substantially Equivalent on June 6, 2014. The device falls under product code PAW (Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement), a Class II device regulated under 21 CFR 870.3470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2014
- Date Received
- April 24, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
- Device Class
- Class II
- Regulation Number
- 870.3470
- Review Panel
- CV
- Submission Type
To repair or replace chordae tendinae.