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2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Reverse Central Venous Recanalization System

Device class

Class II (moderate risk)

Regulation

21 CFR 870.1342

Medical specialty

Cardiovascular

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.

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