QJH · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1342
Classification
FDA Product Code
QJH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.1342
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.