Affinity Cvr

• • Terminated Z-0645-2018 FDA Class II ·initiated 16 Jan 2018

  Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.

• • Terminated Z-0476-2008 FDA Unclassified (pre-2012) ·initiated 1 Oct 2007 ·via K936003, on the same 510(k)

  Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin

• • Terminated Z-0815-04 FDA Unclassified (pre-2012) ·initiated 25 Mar 2004 ·via K936003, on the same 510(k)

  An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K936003 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface

  Class II

  FDA 510(k) K973760 Active Cleared 18 Feb 1998

• Affinity Blood Pump System

  Class II

  FDA 510(k) K964017 Active Cleared 5 Aug 1997

• Affinity Arterial Blood Filter

  Class II

  FDA 510(k) K952532 Active Cleared 6 Oct 1995

• Avecor Pre-Bypass Filter

  Class II

  FDA 510(k) K940126 Active Cleared 28 Jun 1994

• Affinity Venous Reservior Bag

  Class II

  FDA 510(k) K935717 Active Cleared 10 May 1994

• Myotherm (Tm) Xp Cardioplegia Delivery System

  Class II

  FDA 510(k) K971105 Active Cleared 11 Jul 1997

See all devices from Avecor Cardiovascular, Inc. →