DeviceClearance

Product code QJH— Cardiovascular

Surfacer Inside-Out Access Catheter System

Classification name
Reverse Central Venous Recanalization System
Device class
Class 2
Regulation
21 CFR 870.1342
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QJH under 21 CFR 870.1342, via openFDA

Market context for product code QJH

FDA has cleared 2 devices under product code QJH between 2020 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QJH

Recent clearances under product code QJH

Data sourced from openFDA. This site is unofficial and independent of the FDA.