Question 1

What types of medical devices does Vascutek Ltd manufacture?

Accepted Answer

Vascutek Ltd specializes in vascular medical devices, primarily synthetic vascular grafts and animal-derived cardiovascular patches. Their synthetic grafts, such as the Gelweave Vascular Prostheses, are designed for arterial and venous applications, often used in bypass surgeries. Additionally, they produce cardiovascular patches like the Thoraflex Hybrid, which are used for surgical repairs in the cardiovascular system. These devices are tailored for procedures requiring durable vascular reconstruction.

Question 2

Where is Vascutek Ltd based, and where are their devices primarily used?

Accepted Answer

Vascutek Ltd is headquartered in the United States. Their devices are manufactured and intended for use in the US market, adhering to applicable medical device regulations in that region. The company’s focus on vascular grafts and patches aligns with surgical needs within the US healthcare system.

Question 3

Which regulatory registries or databases list Vascutek Ltd’s devices?

Accepted Answer

Vascutek Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.

Question 4

How are Vascutek Ltd’s devices classified under medical device regulations?

Accepted Answer

Vascutek Ltd’s devices fall under FDA’s Class II and Class III classifications. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices are higher risk and typically require premarket approval due to insufficient data through other means. The classification depends on the device’s intended use and potential health impact, such as the complexity of vascular grafts or patches.

Device	Model / Reference	Registries	Class	Status
Gelweave Branched Vascular Grafts With Radiopaque Markers	K093817	FDA 510(k)	Class II	Active
Gelweave Vascular Grafts	K162794	FDA 510(k)	Class II	Active
Vascutek Gelsoft Plus ERS Vascular Graft	K202703	FDA 510(k)	Class II	Active
Extra Soft/Extra Low Woven Vascular Prothesis	K910863	FDA 510(k)	Class II	Active
Vascutek Gelweave Vascular Graft	K952293	FDA 510(k)	Class II	Active
Eptfe Vascular Prosthesis; Sealptfe	K030999	FDA 510(k)	Class II	Active
Vascutek Cobrahood Eptfe Vascular Grafts	K091778	FDA 510(k)	Class II	Active
Gelweave Ante-Flo With Collar And Gelweave 4 Branch Plexus With Collar	K040829	FDA 510(k)	Class II	Active
Externally Reinforced Triaxial Prosthesis	K910864	FDA 510(k)	Class II	Active
Vascusoft (vp1200k) Knitted Vascular Prosthesis	K910866	FDA 510(k)	Class II	Active
Temporary Limb Salvage Shunt	K070323	FDA 510(k)	Class II	Active
Gelweave™ Vascular Prostheses	K241550	FDA 510(k)	Class II	Active
Vascutek Branched Gelweave	K090987	FDA 510(k)	Class II	Active
Triaxil (vp50k) Knitted Vascular Prosthesis	K910865	FDA 510(k)	Class II	Active
Modification To Eptfe Graft	K041528	FDA 510(k)	Class II	Active
Gelsoft Plus Ers	K034010	FDA 510(k)	Class II	Active
Vascutek Cannula Graft, Model Cgs2008s	K081560	FDA 510(k)	Class II	Active
Vascutek Gelweave Siena Collared Anteflo And Plexus With Radiopaque Markers	K060142	FDA 510(k)	Class II	Active
Vascutek Twillweave Vascular Graft	K964959	FDA 510(k)	Class II	Active
Thoraflex™ Hybrid	P210006	FDA PMA	Class III	Active

VASCUTEK LTD

What VASCUTEK LTD makes

Frequently asked questions

Information

Catalogue (2520)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)