# DEN190038: Surfacer Inside-Out Access Catheter System

- Pathway: De Novo (Direct)
- Applicant: Bluegrass Vascular Technologies, Inc.
- Decided: Feb 10, 2020 after 179 days
- Product code: QJH (Reverse Central Venous Recanalization System)
- Device class: 2
- Regulation: 21 CFR 870.1342
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K252527: Surfacer Inside-Out Access Catheter System (2025), 0 descendants of its own

## Indications for use
The Surfacer Inside-Out Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

Source page: https://510kreport.com/device/DEN190038
Methodology: https://510kreport.com/methodology