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Reverse Central Venous Recanalization System

FDA product code QJH · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1342
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-09-10 – 2025-09-10

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.

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