Heyer-Schulte Syringo Peritoneal Shunt

• 5 recalls, same reason

  • Terminated Z-1047-201 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011
  • Terminated Z-1049-2012 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011
  • Terminated Z-1048-2012 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011
  • Terminated Z-1051-2012 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011
  • Terminated Z-1050-2012 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011

  The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.

510(k) Number

K854049 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• V. Mueller Pneumo-Intestinal 15 Vascular & 30 Stap

  Class I

  FDA 510(k) K854568 Active Cleared 2 Dec 1985

• Gauderer Gastrostomy Button

  Class II

  FDA 510(k) K843392 Active Cleared 11 Oct 1984

• Heyer-Schulte(R) One Piece Shunt Vent. Cath. Intro

  Class I

  FDA 510(k) K873771 Active Cleared 18 Dec 1987

• Field-Lee Brain Biopsy Needle

  Class I

  FDA 510(k) K801760 Active Cleared 9 Sep 1980

• V-Mueller Inverted Linear Anastomosis Instruments

  Class II

  FDA 510(k) K850947 Active Cleared 17 Apr 1985

• Laser Mirror

  Not classified

  FDA 510(k) K840982 Active Cleared 6 Mar 1984

See all devices from American V. Mueller →