Flo-Thru

• • Ongoing Z-1523-2024 FDA Class II ·initiated 22 Feb 2024

  The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).

• • Ongoing Z-0663-2024 FDA Class II ·initiated 6 Dec 2023

  Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

• • Terminated Z-1019-2022 FDA Class II ·initiated 1 Apr 2022

  There is a potential for foreign matter.

510(k) Number

K981624 ↗

FDA Product Code

DXC

Device Class

Class II

Regulation

21 CFR Part 870.4450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Tissue Patch, Tissue Graft

  Class II

  FDA 510(k) K921895 Active Cleared 4 Nov 1992

• Peri-Strips Dry - Staple Line Reinforcement

  Class II

  FDA 510(k) K971048 Active Cleared 9 May 1997

• Vascu-Guard

  Class II

  FDA 510(k) K942010 Active Cleared 7 Jul 1994

• Bvi Sling

  Class II

  FDA 510(k) K002233 Active Cleared 13 Oct 2000

• Peri-Guard Pericardium

  Class II

  FDA 510(k) K961811 Active Cleared 13 Jun 1996

• Peri-Guard, Cv Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc Open recall

  Class II

  FDA 510(k) K983162 Active Cleared 9 Oct 1998

See all devices from Bio-Vascular, Inc. →