Sulzer Vascutek ePTFE Vascular Prosthesis

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K992832 ↗

FDA Product Code

DSY

Device Class

Class II

Regulation

21 CFR Part 870.3450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• APR Metasul Acetabular Insert

  Class III

  FDA 510(k) K993569 Active Cleared 1 Dec 1999

• Sulzer Vascutek Gelsoft Vascular Prosthesis

  Class II

  FDA 510(k) K990503 Active Cleared 9 Dec 1999

• Modified to Modular FR Severe Bone Loss Trauma

  Class II

  FDA 510(k) K002324 Active Cleared 24 Aug 2000

• Sulzer Vascutek Sealptfe Vascular Prosthesis

  Class II

  FDA 510(k) K993667 Active Cleared 28 Jan 2000

• Natural-Knee(R) with CSTI(TM)

  Class III

  FDA PMA P940002 Active Approved 21 Mar 1997

• What is the Vascutek ePTFE Vascular Prosthesis used for?

  The Vascutek ePTFE Vascular Prosthesis is designed for vascular procedures requiring bypass, reconstruction, or creation of arteriovenous conduits for blood access. Its porous ePTFE structure promotes blood flow and tissue integration, making it suitable for applications where a synthetic graft is needed to restore or reroute circulation.

• How is the Vascutek ePTFE Vascular Prosthesis supplied, and what sizes are available?

  This prosthesis is supplied in various sizes, differentiated by FEI numbers such as 1721676, 1018233, and others listed in the registry. The device is intended for single-use in controlled clinical environments like operating rooms or interventional suites, ensuring sterile and safe surgical application.

• Is the Vascutek ePTFE Vascular Prosthesis sterile, and how should it be handled?

  The device is provided sterile by the manufacturer, Sulzermedica, with specific sterility and handling instructions included to ensure proper surgical use. Adherence to these guidelines is critical to maintain sterility and prevent contamination before and during procedures.

• Can the Vascutek ePTFE Vascular Prosthesis be reused, or is it intended for single-use?

  The Vascutek ePTFE Vascular Prosthesis is explicitly intended for single-use applications. Its design and sterility assurances are tailored for controlled clinical settings, where reuse would compromise patient safety and regulatory compliance.

• What regulatory pathway does the Vascutek ePTFE Vascular Prosthesis follow?

  The device holds FDA 510(k) clearance under the Traditional pathway and is classified as a Class 2 Cardiovascular device with product code DSY. It is regulated under FDA regulations (870.3450), ensuring it meets established safety and effectiveness standards for vascular grafts.