Not Cleared Direct

DEN190038 - Surfacer Inside-Out Access Catheter System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190038 · Bluegrass Vascular Technologies, Inc. · Cardiovascular device
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Feb 2020
Decision
179d
Days
Class 2
Risk

DEN190038 is an FDA 510(k) submission (not cleared) for the Surfacer Inside-Out Access Catheter System. Classified as Reverse Central Venous Recanalization System (product code QJH), Class II - Special Controls.

Submitted by Bluegrass Vascular Technologies, Inc. (San Antonio, US). The FDA issued a Not Cleared (DENG) decision on February 10, 2020 after a review of 179 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1342 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all Bluegrass Vascular Technologies, Inc. devices

Submission Details

510(k) Number DEN190038 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 15, 2019
Decision Date February 10, 2020
Days to Decision 179 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics

Device Classification

Product Code QJH Reverse Central Venous Recanalization System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1342
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.