Cardiovascular Spring Guides

• • Ongoing Z-3062-2024 FDA Class II ·initiated 10 Jul 2024

  Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.

510(k) Number

K770977 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

• Open Ended Guidewire

  Class II

  FDA 510(k) K912878 Active Cleared 11 Sep 1991

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