QJH
- Product code
- QJH
- Device name
- Reverse Central Venous Recanalization System
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1342
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252527 | 2025-09-10 | Merit Medical System, Inc. | Surfacer Inside-Out Access Catheter System |
Official FDA classification page: QJH
Classification and pathway per current FDA publications. Data from openFDA (CC0).