QJHClass II
Reverse Central Venous Recanalization System
21 CFR 870.1342 / Cardiovascular
QJH is the FDA product code for Reverse Central Venous Recanalization System, a class II device type, regulated under 21 CFR 870.1342. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QJH
- Device name
- Reverse Central Venous Recanalization System
- FDA 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.
- Regulation
- 21 CFR 870.1342
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code QJH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code QJH| Applicant | Clearances |
|---|---|
| Bluegrass Vascular Technologies, Inc. | 1 |
| Merit Medical System, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.