Scimed Choice Pt Vision Ptca Guide Wire

• • Terminated Z-0592-03 FDA Unclassified (pre-2012) ·initiated 19 Nov 2002

  Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire.

• • Terminated Z-0591-03 FDA Unclassified (pre-2012) ·initiated 22 Aug 2002

  Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm

• • Terminated Z-0589-03 FDA Unclassified (pre-2012) ·initiated 16 Jul 2002

  Labeled as J tip but may be straight tip.

510(k) Number

K962572 ↗

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. →