Pulse*spray Infusion System

• 2 recalls, same reason

  • Terminated Z-3266-2011 FDA Unclassified (pre-2012) ·initiated 28 Jan 2011 ·via K951509, on the same 510(k)
  • Terminated Z-3267-2011 FDA Unclassified (pre-2012) ·initiated 28 Jan 2011 ·via K951509, on the same 510(k)

  The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires.

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

510(k) Number

K951509 ↗

FDA Product Code

QEY

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Microguide Lesion Marking System

  Class I

  FDA 510(k) K923120 Active Cleared 1 Sep 1992

• Pulse*spray Infusion System

  Class II

  FDA 510(k) K961763 Active Cleared 17 Jul 1996

• Angiography Syringe Kits

  Class II

  FDA 510(k) K933846 Active Cleared 13 Dec 1994

• Pulse*spray Infusion System

  Class II

  FDA 510(k) K950907 Active Cleared 17 May 1995

• Pulse*spray Infusion System

  Class II

  FDA 510(k) K951602 Active Cleared 14 Jun 1995