Data / Medical devices / Reverse Central Venous Recanalization System
Reverse Central Venous Recanalization System (QJH): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Reverse Central Venous Recanalization System (product code QJH, Class 2, 21 CFR 870.1342). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on September 10, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QJH
- Device class
- 2
- Regulation
- 870.1342
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Mexico | 1 |
Makers of Reverse Central Venous Recanalization System
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 |
|---|---|---|---|---|---|---|---|---|
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer for export, Specification developer | 2 | September 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 10, 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.