Data / Medical devices / Holder, Heart-Valve, Prosthesis
Holder, Heart-Valve, Prosthesis (DTJ): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Holder, Heart-Valve, Prosthesis (product code DTJ, Class 1, 21 CFR 870.3935). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on August 27, 1996, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DTJ
- Device class
- 1
- Regulation
- 870.3935
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| China | 1 |
| Italy | 1 |
| Singapore | 1 |
Makers of Holder, Heart-Valve, Prosthesis
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corcym S.r.l. | SALUGGIA Vercelli, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences LLC | Draper, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fong's Engineering & Manufacturing Private Limited | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Heart Valves Division | Santa Ana, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. (Minneapolis, MN 55447) | Minneapolis, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| On-X Life Technologies Inc. | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 27, 1996. 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.