QJH — Reverse Central Venous Recanalization System Class II
FDA product code QJH covers "Reverse Central Venous Recanalization System", a Class II medical device regulated under 21 CFR 870.1342. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QJH
- Device Class
- Class II
- Regulation Number
- 870.1342
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.