# K252527: Surfacer Inside-Out Access Catheter System

- Pathway: 510(k) (Special)
- Applicant: Merit Medical System, Inc.
- Decided: Sep 10, 2025 after 30 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
Longest line of descent: 1 generation back to DEN190038 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190038: Surfacer Inside-Out Access Catheter System, Bluegrass Vascular Technologies, Inc. (2020) Summary page 5.

## 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/K252527
Methodology: https://510kreport.com/methodology