Surfacer Inside-Out Access Catheter System

Reverse Central Venous Recanalization System

Bluegrass Vascular Technologies, Inc.

The following data is part of a De Novo classification by Bluegrass Vascular Technologies, Inc. with the FDA for Surfacer Inside-out Access Catheter System.

Pre-market Notification Details

DeNovo IDDEN190038
Device Name:Surfacer Inside-Out Access Catheter System
ClassificationReverse Central Venous Recanalization System
Applicant Bluegrass Vascular Technologies, Inc. 12500 Network Boulevard, Suite 308 San Antonio,  TX  78249
ContactGabriele G. Niederauer
Product CodeQJH  
CFR Regulation Number870.1342 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardCardiovascular
Classification AdvisoryCardiovascular
Date Received2019-08-15
Decision Date2020-02-10
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
00860003451601 DEN190038 000

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