Not Cleared Direct

DEN220026 - VasQ (FDA 510(k) Clearance)

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

DEN220026 · Laminate Medical Technologies , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
515d
Days
Class 2
Risk

DEN220026 is an FDA 510(k) submission (not cleared) for the VasQ. Classified as Extravascular Support For An Arteriovenous Fistula For Vascular Access (product code QVQ), Class II - Special Controls.

Submitted by Laminate Medical Technologies , Ltd. (Tel Aviv, IL). The FDA issued a Not Cleared (DENG) decision on September 26, 2023 after a review of 515 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4600 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 515 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Laminate Medical Technologies , Ltd. devices

Submission Details

510(k) Number DEN220026 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 29, 2022
Decision Date September 26, 2023
Days to Decision 515 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
390d slower than avg
Panel avg: 125d · This submission: 515d
Pathway characteristics

Device Classification

Product Code QVQ Extravascular Support For An Arteriovenous Fistula For Vascular Access
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4600
Definition This Device Is A Permanent Implant Which Is Surgically Placed Outside And/or Around An Artery And/or Vein To Provide External Support To Arteriovenous Fistulas Created For Vascular Access By Means Of Vascular Surgery.
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.