Cleared Special

K142062 - SPIRAL FLOW PERIPHERAL VASCULAR GRAFT

K142062 is an FDA 510(k) clearance for SPIRAL FLOW PERIPHERAL VASCULAR GRAFT, manufactured by Vascular Flow Technologies, Ltd.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Special 510(k) pathway after a 113-day FDA review.

K142062 · Vascular Flow Technologies, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
113d
Days
Class 2
Risk

K142062 is an FDA 510(k) clearance for the SPIRAL FLOW PERIPHERAL VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Vascular Flow Technologies, Ltd. (Dundee, GB). The FDA issued a Cleared decision on November 20, 2014 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142062

510(k) Number K142062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2014
Decision Date November 20, 2014
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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.

Regulatory Peers - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 181
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K142062.
Gelweave Vascular Grafts
K162794 · Vascutek, Ltd. · Jun 2017
FUSION Vascular Graft
K153523 · Maquet Cardiovascular, LLC · Feb 2016
Spiral Flow Peripheral Vascular Graft
K150389 · Vascular Flow Technologies, Ltd. · May 2015
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
K141124 · Vascular Flow Technologies, Ltd. · May 2014
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
K131778 · Maquet Cardiovascular, LLC · Nov 2013
GORE ACUSEAL VASCULAR GRAFT
K130215 · W.L. Gore & Associates, Inc. · Apr 2013
K142062 · SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
Download PDF FDA Summary Vascular Flow Technol…