Streerable Ptca Guidewire

• 2 recalls, same reason

  • Terminated Z-1487-2009 FDA Unclassified (pre-2012) ·initiated 12 May 2009
  • Terminated Z-1486-2009 FDA Unclassified (pre-2012) ·initiated 12 May 2009

  Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the

510(k) Number

K011968 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiovascular Spring Guides Open recall

  Class II

  FDA 510(k) K770977 Active Cleared 14 Jun 1977

• Lrm Produces Guidewires on an Oem Basis for Manufacturers, Kit Assemblers, and Distributors.

  Class II

  FDA 510(k) K960866 Active Cleared 5 Apr 1996

• Lake Region Variable Stiffness Guidewire (Vsgw)

  Class II

  FDA 510(k) K871882 Active Cleared 15 Sep 1987

• Fasiculated Nail

  Class II

  FDA 510(k) K861365 Active Cleared 6 May 1986

• Torque Handle Device for Guidewire

  Class II

  FDA 510(k) K905639 Active Cleared 20 Feb 1991

• Steerable Guidewire

  Class II

  FDA 510(k) K022813 Active Cleared 14 Feb 2003

See all devices from Lake Region Mfg., Inc. →