Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
The Nonabsorbable Expanded Polytetrafluoroethylene (ePTFE) Surgical Suture for Chordae Tendinae Repair or Replacement is a cardiovascular implant used to repair or replace the chordae tendinae of the heart. It is classified as a Class 2 device under regulation 870.3470 in the Cardiovascular medical specialty, requiring 510(k) premarket notification. The device is both an implant and life-sustaining, reflecting its critical role in maintaining proper heart valve function. General controls and special controls apply to this device.
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Basic Information
- Product Code
- PAW
- Device Class
- FDA class 2
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
To repair or replace chordae tendinae.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252126 | MitraPatch Mitral Valve Repair System | Dec 04, 2025 | Substantially Equivalent | Chawla Heart Technologies, LLC |
| K141060 | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | Jun 06, 2014 | Substantially Equivalent | On-X Life Technologies, Inc. |
| K121173 | CHORD-X EPTFE SUTURE | Aug 16, 2012 | Substantially Equivalent | On-Xlifetechnologies |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.