Scimed Choice PTCA Guide Wire

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

Full name

Scimed Choice(Tm) Ptca Guide Wire

510(k) Number

K943192 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Triguide Guide Catheters

  Class II

  FDA 510(k) K953515 Active Cleared 19 Sep 1995

• Scimed Viper

  Class II

  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

  Class II

  FDA 510(k) K914312 Active Cleared 22 Nov 1991

• Scimed Triguide Guide Catheter

  Class II

  FDA 510(k) K944537 Active Cleared 21 Oct 1994

• Scimed Pursuit Exchange Ptca Guide Wire

  Class II

  FDA 510(k) K945159 Active Cleared 30 Dec 1994

• Scimed(R) Controlwire(Tm) Guide Wire

  Class II

  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What is the Scimed Choice PTCA Guide Wire used for?

  The Scimed Choice PTCA Guide Wire is designed specifically for percutaneous transluminal coronary angioplasty (PTCA), a procedure to widen narrowed coronary arteries. It aids in placing angioplasty balloons and other interventional tools by providing mechanical support and stability during catheter manipulation. This reduces trauma to arterial walls while ensuring precise navigation through obstructed vessels, helping restore blood flow during revascularisation.

• Is the Scimed Choice PTCA Guide Wire single-use or reusable?

  This guidewire is intended for single-use only. It is supplied as a non-sterile product, meaning it must be sterilised using appropriate clinical techniques before use in a controlled environment like a cardiac catheterisation laboratory. Single-use design minimises cross-contamination risks and ensures patient safety.

• How should the Scimed Choice PTCA Guide Wire be stored?

  While specific storage conditions are not detailed in the regulatory data, standard medical device precautions should be followed. This includes protecting the device from physical damage, contamination, and extreme temperatures. Ensure it is stored in a clean, dry environment and away from direct sunlight or sources of moisture until ready for use.

• Can the Scimed Choice PTCA Guide Wire be used with MRI imaging?

  No, the Scimed Choice PTCA Guide Wire is explicitly stated as not MRI-compatible. If MRI imaging is required for the patient post-procedure, the guidewire must be removed beforehand to avoid potential risks associated with metallic objects in magnetic fields.

• What regulatory pathway does the Scimed Choice PTCA Guide Wire follow?

  The device is regulated under the FDA’s 510(k) clearance pathway, specifically classified under product code DQO and reviewed by the Cardiovascular Advisory Committee. It was granted clearance as substantially equivalent to a predicate device, with the decision dated November 22, 1994 (K943192). This classification ensures it meets established safety and effectiveness standards for coronary intervention tools.