Daig Pacemaker Lead Adaptor

• • Terminated Z-0580-2010 FDA Unclassified (pre-2012) ·initiated 1 Sep 2009 ·via K870562, on the same 510(k)

  The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.

• • Terminated Z-0120-2007 FDA Unclassified (pre-2012) ·initiated 18 Jul 2006 ·via K870562, on the same 510(k)

  Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.

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

510(k) Number

K870562 ↗

FDA Product Code

DTD

Device Class

Class II

Regulation

21 CFR Part 870.3620

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Adapter Kit

  Class II

  FDA 510(k) K781864 Active Cleared 19 Dec 1978

• Pacemaker, Perm. & Temp., Electrode

  Class III

  FDA 510(k) K772197 Active Cleared 30 Jan 1978

• Permanent Lead Intraducer

  Class II

  FDA 510(k) K800356 Active Cleared 28 May 1980

• Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K800352 Active Cleared 28 May 1980

• Daig Pacel(Tm) Flow Directed Pacing Catheter

  Class II

  FDA 510(k) K890794 Active Cleared 20 Jun 1989

• Unipolar Lead Configuration Conductor

  Class III

  FDA 510(k) K800348 Active Cleared 28 May 1980

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