Stubbie Steerable Guidewire

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K873543 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Diagnostic Intravascular Catheter

  Class II

  FDA 510(k) K925813 Active Cleared 23 Mar 1994

• Angiographic Catheter

  Class II

  FDA 510(k) K926243 Active Cleared 16 Aug 1993

• Retriever II

  Class II

  FDA 510(k) K964210 Active Cleared 31 Oct 1997

• Infusion Catheter W/Side Holes

  Class II

  FDA 510(k) K854000 Active Cleared 5 Nov 1985

• Guide Wire Introducer

  Class II

  FDA 510(k) K873972 Active Cleared 1 Apr 1988

• Turbo Tracker

  Class II

  FDA 510(k) K960806 Active Cleared 2 May 1996

See all devices from Target Therapeutics →

• What is the Stubbie Steerable Guidewire used for?

  The Stubbie Steerable Guidewire is a cardiovascular guide wire device intended for use in catheter-based procedures within the cardiovascular system, as indicated by its classification under product code DQX and regulation 870.1330 for guide wires.

• Is the Stubbie Steerable Guidewire sterile and single-use?

  Yes, the device is supplied as a sterile, single-use product, meaning it is intended for one patient and one procedure only, and must not be reprocessed or reused to avoid infection risk or device failure.

• What regulatory clearance does the Stubbie Steerable Guidewire have?

  The Stubbie Steerable Guidewire received FDA 510(k) clearance under number K873543 on December 3, 1987, following a traditional review process, and was found substantially equivalent to a predicate device.

• Who manufactures the Stubbie Steerable Guidewire and where are they located?

  The device is manufactured by Target Therapeutics, located at 2100 S. Sepulveda Blvd., Los Angeles, CA 90025, United States, as indicated in the manufacturer address and contact details from the 510(k) submission.