Embolectomy Catheter

• • Terminated Z-2911-2016 FDA Class II ·initiated 7 Jul 2016

  Arrow is recalling due to incorrect labeling of products.

• 3 recalls, same reason

  • Terminated Z-1471-2009 FDA Unclassified (pre-2012) ·initiated 25 Mar 2009
  • Terminated Z-1473-2009 FDA Unclassified (pre-2012) ·initiated 25 Mar 2009
  • Terminated Z-1472-2009 FDA Unclassified (pre-2012) ·initiated 25 Mar 2009

  The inflation arm tubing may separate from the stopcock adapter.

510(k) Number

K902327 ↗

FDA Product Code

DXE

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Carotid Bypass Shunt

  Class II

  FDA 510(k) K860742 Active Cleared 28 May 1986

• Multilumen Intravenous Infusion Catheter

  Class I

  FDA 510(k) K821220 Active Cleared 9 Jul 1982

• Swan Ganz

  Class II

  FDA 510(k) K771043 Active Cleared 20 Dec 1977

• Tweetheart #102 Fetal/Neonatal Heartbeat Annunciat

  Class II

  FDA 510(k) K852704 Active Cleared 26 Nov 1985

• Introducers

  Class II

  FDA 510(k) K790034 Active Cleared 1 Feb 1979

• Carotid Bypass Shunt with Sampling Arm

  Class II

  FDA 510(k) K860743 Active Cleared 28 May 1986

See all devices from Clincal Instruments Corp. →