Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft

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

510(k) Number

K981079 ↗

FDA Product Code

DSY

Device Class

Class II

Regulation

21 CFR Part 870.3450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for a-V Access

  Class II

  FDA 510(k) K004011 Active Cleared 27 Mar 2001

• Vascular Graft Prosthesis Expanded Micr

  Class II

  FDA 510(k) K830543 Active Cleared 19 Jul 1983

• 10 and 12 French Vessel Dilators

  Class II

  FDA 510(k) K874738 Active Cleared 2 May 1988

• Impra Carboflo Eptfe Vascular Graft

  Class II

  FDA 510(k) K962639 Active Cleared 3 Oct 1996

• Bi-Directional Tunneler

  Class II

  FDA 510(k) K991027 Active Cleared 22 Apr 1999

• Impra Peritoneal Catheter

  Class II

  FDA 510(k) K823857 Active Cleared 26 Jan 1983

See all devices from Impra, Inc. →

• What is the Venaflo PTFE Vascular Graft used for?

  The Venaflo PTFE Vascular Graft is designed as a synthetic conduit for vascular access in cardiovascular applications. It facilitates blood flow in hemodialysis and arteriovenous (AV) conduit procedures, helping to maintain patency and reduce stenosis. The standard graft features a cuffed venous end, while the Venaflo Graft with Carbon includes a carbon-lined lumen to improve surface properties, both tailored for subcutaneous AV access.

• How is the Venaflo PTFE Vascular Graft supplied and what are its sterility and reuse details?

  The Venaflo PTFE Vascular Graft is supplied sterile and is intended for single-use only. This ensures patient safety by preventing contamination and cross-infection. The grafts are not designed for reuse, as repeated use could compromise sterility and integrity, potentially leading to adverse clinical outcomes.

• What sizes and configurations are available for the Venaflo PTFE Vascular Graft?

  The Venaflo PTFE Vascular Graft is available in multiple sizes and configurations, categorized by specific registration numbers. These include variants for both standard ePTFE grafts and the carbon-lined version, all designed for 6mm and greater diameter applications. The exact sizes and configurations can be identified through the registration numbers listed in the FDA database.

• How should the Venaflo PTFE Vascular Graft be stored?

  The Venaflo PTFE Vascular Graft must be stored according to sterile medical device protocols to maintain its integrity before use. This includes keeping it in a sealed, sterile packaging until the time of procedure, protecting it from contamination, moisture, and physical damage. Proper storage ensures the graft remains sterile and functional for its intended single-use application.

• What regulatory pathway does the Venaflo PTFE Vascular Graft follow?

  The Venaflo PTFE Vascular Graft is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K981079. It is classified as a Class II medical device under the DSY product code, which pertains to Prosthesis, Vascular Graft, of 6mm and Greater Diameter. This classification indicates that the device has undergone evaluation to ensure its safety and effectiveness for its intended use in vascular access procedures.