Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch

• • Terminated Z-1593-2011 FDA Unclassified (pre-2012) ·initiated 7 Dec 2010 ·on shared 510(k) K962342

  One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.

• • Terminated Z-2064-2010 FDA Unclassified (pre-2012) ·initiated 24 May 2010 ·on shared 510(k) K962342

  Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K962342 ↗

FDA Product Code

DXZ

Device Class

Class II

Regulation

21 CFR Part 870.3470

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiac Electrode K760443

  Class III

  FDA 510(k) K760443 Active Cleared 26 Aug 1976

• Meadox Exxcel Eptfe Vascular Graft

  Class II

  FDA 510(k) K962433 Active Cleared 17 Mar 1997

• Ms Classique Balloon Catheter

  Class II

  FDA 510(k) K942293 Active Cleared 18 Oct 1994

• Meadox(R) Surgimed Olbert Catheter System(R)

  Class II

  FDA 510(k) K921706 Active Cleared 20 May 1993

• Naviguide Hydrophilic Guide Wire

  Class II

  FDA 510(k) K943358 Active Cleared 2 Jun 1995

• Hemashield Microvel Velour Knitted Vascular Graft

  Class II

  FDA 510(k) K954848 Active Cleared 1 Feb 1996

See all devices from Meadox Medicals, Div. Boston Scientific Corp. →