Data / Medical devices / Controller, Infusion, Intravascular, Electronic
Controller, Infusion, Intravascular, Electronic (LDR): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Controller, Infusion, Intravascular, Electronic (product code LDR, Class 2, 21 CFR 880.5725). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 60 510(k) clearances under this code, the latest on October 7, 2024, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LDR
- Device class
- 2
- Regulation
- 880.5725
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Thailand | 1 |
| Mexico | 1 |
Makers of Controller, Infusion, Intravascular, Electronic
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 |
|---|---|---|---|---|---|---|---|---|
| Deka Research & Development Corp. | Manchester, NH, United States | Specification developer | 2 | October 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | April 16, 1991 | 0 | 0 | 0 | api.fda.gov |
| Epic International (Thailand) Co., Ltd. | Amphur Pluakdaeng Rayong, Thailand | Manufacturer | 1 | April 29, 1985 | 0 | 0 | 0 | api.fda.gov |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Complaint file establishment, Manufacturer | 1 | October 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| CardioRenal Systems, Inc. | Milford, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 7, 2024. 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.