QJH

Reverse Central Venous Recanalization System

Product code
QJH
Device name
Reverse Central Venous Recanalization System
Device class
Class 2
21 CFR
21 CFR 870.1342
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-09-10.

NumberDecision dateApplicantDevice nameSummary
K2525272025-09-10Merit Medical System, Inc.Surfacer Inside-Out Access Catheter SystemPDF

1 summaries are archived here for direct download.

Official FDA classification page: QJH
Classification and pathway per current FDA publications. Data from openFDA (CC0).