FDA product code QJH: Reverse Central Venous Recanalization System
QJH is the FDA product code for reverse central venous recanalization system. It is a Class II device, regulated under 21 CFR 870.1342 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QJH, 1 in the last five years. The average 510(k) review took 30 days (median 30); 30 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A reverse central venous recanalization system is a prescription device intended for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.
Classification
| Field | Value |
|---|---|
| Device name | Reverse Central Venous Recanalization System |
| Device class | Class II |
| Regulation | 21 CFR 870.1342 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QJH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 30 |
Compare with all 510(k) review times · Search every QJH clearance
Top QJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Merit Medical System, Inc. | 1 | 2025-09-10 |
Most recent QJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252527 | Merit Medical System, Inc. | Surfacer Inside-Out Access Catheter System | 2025-09-10 | 30 |
Recalls for QJH devices
openFDA lists no recalls for product code QJH.
Frequently asked questions
What is FDA product code QJH?
QJH is the FDA product code for reverse central venous recanalization system. It is a Class II device, regulated under 21 CFR 870.1342 and reviewed by the Cardiovascular panel.
What device class is QJH?
Class II, regulation 21 CFR 870.1342. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJH?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most QJH clearances?
Merit Medical System, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QJH
- Run a recall and safety report across every QJH manufacturer
- Watch product code QJH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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