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510(k) DEN190038

Surfacer Inside-Out Access Catheter System by Bluegrass Vascular Technologies, Inc. — Product Code QJH

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 10, 2020
Date Received
August 15, 2019
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reverse Central Venous Recanalization System
Device Class
Class II
Regulation Number
870.1342
Review Panel
CV
Submission Type

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.

Other clearances for product code QJH

  • K252527 — Surfacer Inside-Out Access Catheter System (September 10, 2025)