Spiral Flow Peripheral Vascular Graft

Q: What is the product code of K142062?

The FDA product code is DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.

FDA 510(k) K142062 · Vascular Flow Technologies, Ltd.

Substantially Equivalent

510(k) numberK142062

Submission

Device name: Spiral Flow Peripheral Vascular Graft
Applicant: Vascular Flow Technologies, Ltd.
Dundee, GB
Received: July 30, 2014
Decision date: November 20, 2014
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.3450
Specialty: Cardiovascular
Implant: Yes

Other 510(k)s with product code DSY

510(k)	Device	Applicant	Decision
K252445	Fusion Bioline Vascular GraftDSY · Traditional	Maquet Cardiovascular, LLC	04/27/2026SE
K252277	Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)DSY · Traditional	Vascular Flow Technologies Limited	10/20/2025SE
K241550	Gelweave Vascular ProsthesesDSY · Traditional	Vascutek, Ltd.	02/27/2025SE
K241070	Gelsoft Plus Vascular ProsthesesDSY · Traditional	Vascutek, Ltd.	11/15/2024SE
K231972	Advanta VXT Vascular Graft, Flixene Vascular GraftDSY · Traditional	Atrium Medical Corporation	03/28/2024SE
K240083	GORE® PROPATEN® Vascular GraftDSY · Traditional	W. L. Gore & Associates, Inc.	03/01/2024SE
K233783	exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsDSY · Traditional	Peca Labs, Inc.	01/17/2024SE
K232312	GORE® PROPATEN® Vascular GraftDSY · Traditional	W. L. Gore & Associates, Inc.	01/09/2024SE
K233551	GORE® ACUSEAL Vascular GraftDSY · Traditional	W. L. Gore & Associates, Inc.	12/19/2023SE
K231505	GORE® ACUSEAL Vascular GraftDSY · Special	W. L. Gore & Associates, Inc.	06/23/2023SE

More from W. L. Gore & Associates, Inc.

510(k)	Device	Decision
K252277	Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)DSY · Traditional	10/20/2025SE
K150389	Spiral Flow Peripheral Vascular GraftDSY · Special	05/06/2015SE
K141124	Spiral Flow Vascular Arteriovenous GraftDSY · Special	05/30/2014SE

Questions and answers

When was Spiral Flow Peripheral Vascular Graft cleared by the FDA?

Spiral Flow Peripheral Vascular Graft (K142062) received a 510(k) decision of Substantially Equivalent on November 20, 2014, 113 days after the submission was received.

What is the product code of K142062?

The FDA product code is DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.