Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K964551 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

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 Choice Super Support PTCA Guide Wire used for?

  It is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other procedures, providing steerability for navigation in coronary arteries.

• What are the key specifications of the Choice Super Support PTCA Guide Wire?

  The device has a nominal diameter of 0.014 inches and is available in two tip configurations: straight shapeable and pre-formed J-Tip, allowing flexibility in procedural use based on anatomical needs.

• How is the Choice Super Support PTCA Guide Wire supplied and by whom?

  It is supplied by Scimed Life Systems, Inc., manufactured at their facility in Maple Grove, Minnesota, and was cleared under FDA 510(k) submission K964551 on May 21, 1997.