Distaflo Bypass Graft

• • Terminated Z-0785-2016 FDA Class II ·initiated 5 Jan 2016

  Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.

• • Terminated Z-0786-2016 FDA Class II ·initiated 5 Jan 2016

  Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.

510(k) Number

K983861 ↗

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. →