Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612515

FEI Number

3002808437

Entity Name

VASCUTEK LTD.

City/State/Country

Inchinnan Renfrewshire, GB

Establishment Address

Newmains Avenue, Inchinnan Renfrewshire PA4 9RR, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VASCUTEK LTD. (Owner Number: 10039218)

Owner / Operator Contact Address

NEWMAINS AVE., INCHINNAN, GB-RFW PA4 9RR, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202703

PMA Number

N/A

All Registered Proprietary Names

Cardiovascular fabric:Gelseal patch, Gelsoft patch, thinwall carotid patch Gelsoft Plus ERS Gelseal Vascular Grafts Gelsoft Plus Vascular Graft Gelweave Valsalva Gelweave Siena collared ante-flo and plexus with radiopaque markers Gelweave vascular grafts Prosthesis, vascular graft, of 6mm and greater diameter. Device name- Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Cardiovascular fabric:Gelseal patch, Gelsoft patch, thinwall carotid patch Prosthesis, vascular graft, of 6mm and greater diameter. Device name- Gelweave Vascular Grafts Gelweave Vascular Prostheses Gelsoft vascular graft Gelweave branched grafts and Siena grafts with and without radiopaque markers Gelsoft Plus ERS Vascular Grafts

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2013-01-22
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2011-12-18
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2011-12-18
MAL	Graft, Vascular, Synthetic/Biologic Composite	Cardiovascular	Class 2	870.3450	2011-12-18
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2013-01-22
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2011-12-18
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2011-12-18
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2011-12-18
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2011-12-18
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2019-02-18
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2020-07-13
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2013-01-22
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2013-01-22
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2019-02-18
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2025-03-03
LWR	Heart-Valve, Non-Allograft Tissue	Unknown	Class 3	N/A	2013-01-22
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2011-12-18
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2011-12-18
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2021-04-13

Official Correspondent

No official correspondent registered.

US Agent Details

Dina Justice Email: dina.justice@terumomedical.com Phone: (301) 9435726

Related Public Records

Same Entity

VASCUTEK LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962639	Impra, Inc.	IMPRA CARBOFLO EPTFE VASCULAR GRAFT	1996-10-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2026	W L Gore & Associates, Inc.	2	GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
Z-0004-2007	Thoratec Corp	3	Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Z-0005-2017	Heartware, Inc.	3	HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Z-0006-2017	HeartWare, Inc	3	HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Z-0015-2007	Thoratec Corp	3	Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612515. Last updated year: 2026. Please use registration number 9612515 when referencing this establishment in official correspondence.