Heartport Endoaortic Clamp Catheter

• • Terminated Z-0085-2010 FDA Unclassified (pre-2012) ·initiated 24 Sep 2009 ·on shared 510(k) K974175

  Spontaneous balloon rupture during use of the product.

• • Terminated Z-0811-05 FDA Unclassified (pre-2012) ·initiated 12 Apr 2005

  Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.

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

510(k) Number

K974175 ↗

FDA Product Code

DWZ

Device Class

Class II

Regulation

21 CFR Part 870.4075

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Directflow Arterial Cannula

  Class II

  FDA 510(k) K990772 Active Cleared 23 Mar 1999

• Heartport Endosinus Catheter

  Class II

  FDA 510(k) K961270 Active Cleared 18 Jun 1996

• Heartport Needle Trocar

  Class II

  FDA 510(k) K965051 Active Cleared 12 Mar 1997

• Heartport Endopulmonary Vent Catheter

  Class II

  FDA 510(k) K981009 Active Cleared 4 Sep 1998

• Heartport Introducer Sheath

  Class II

  FDA 510(k) K972570 Active Cleared 1 Oct 1997

• Heartport Endopulmonary Vent

  Class II

  FDA 510(k) K961245 Active Cleared 18 Jun 1996

See all devices from Heartport, Inc. →