QJH — Reverse Central Venous Recanalization System Class II

FDA Device Classification

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252527merit medical systemSurfacer Inside-Out Access Catheter SystemSeptember 10, 2025
DEN190038bluegrass vascular technologiesSurfacer Inside-Out Access Catheter SystemFebruary 10, 2020