Baxter Hemostasis Valve Introducers

• 2 recalls, same reason

  • Terminated Z-2776-2011 FDA Unclassified (pre-2012) ·initiated 15 Jun 2011 ·on shared 510(k) K981909
  • Terminated Z-2777-2011 FDA Unclassified (pre-2012) ·initiated 15 Jun 2011 ·on shared 510(k) K981909

  Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.

• • Terminated Z-1913-2009 FDA Unclassified (pre-2012) ·initiated 11 May 2009

  Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.

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

510(k) Number

K981909 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Baxter Handle Model 1150

  Class I

  FDA 510(k) K944214 Active Cleared 10 Feb 1995

• Baxter Eptfe Externally Supported Vascular Grafts

  Class II

  FDA 510(k) K944858 Active Cleared 5 Jan 1995

• Fogarty Valvulotome Model 700091

  Class II

  FDA 510(k) K965137 Active Cleared 4 Jun 1997

• Baxter Percutaneous Mechanical Thrombectomy (Pmt) Device, Models PMT0606FD and PMT1206FD

  Class II

  FDA 510(k) K993816 Active Cleared 4 May 2000

• 4.5F Imagecath Coronary Angioscope, Model COV45

  Class II

  FDA 510(k) K952638 Active Cleared 28 Jul 1995

• Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)

  Class II

  FDA 510(k) K964021 Active Cleared 27 Mar 1997

See all devices from Baxter Edwards →