Cleared Special

K240119 - VasQ (FDA 510(k) Clearance)

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

K240119 · Laminate Medical Technologies , Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2024
Decision
31d
Days
Class 2
Risk

K240119 is an FDA 510(k) clearance 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 Cleared decision on February 16, 2024 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4600 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Laminate Medical Technologies , Ltd. devices

Submission Details

510(k) Number K240119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2024
Decision Date February 16, 2024
Days to Decision 31 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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.