Data / Medical devices / Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement (PAW): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement (product code PAW, Class 2, 21 CFR 870.3470). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on December 4, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PAW
- Device class
- 2
- Regulation
- 870.3470
- Medical specialty
- Cardiovascular
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 1 |
| Japan | 1 |
| Vietnam | 1 |
Makers of Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| On-X Life Technologies Inc. | Austin, TX, United States | Specification developer | 1 | June 6, 2014 | 0 | 1 | 0 | api.fda.gov |
| Mani, Inc. (head Office) | UTSUNOMIYA Tochigi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani Hanoi Co. Ltd Pho Yen 2 Factory | Thai Nguyen Province, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.