Scimed Transport Steerable Guide Wire and Access.

• • Terminated Z-0122-2008 FDA Unclassified (pre-2012) ·initiated 14 Jun 2007

  Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.

510(k) Number

K931584 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 7FR. and 8FR. Triguide Guiding Catheter Add. Curve

  Class II

  FDA 510(k) K910987 Active Cleared 29 May 1991

• Scimed 6 French Micro-Max Guide Catheter

  Class II

  FDA 510(k) K953909 Active Cleared 13 Nov 1995

• Scimed Encore Inflation Device, Model SM2500

  Class II

  FDA 510(k) K903503 Active Cleared 9 Oct 1990

• Scimed Sideliner

  Class II

  FDA 510(k) K922706 Active Cleared 10 Dec 1992

• Scimed Angiographic Catheters

  Class II

  FDA 510(k) K992142 Active Cleared 21 Jul 1999

• Scimed Viper Catheter

  Class II

  FDA 510(k) K915347 Active Cleared 17 Aug 1992

See all devices from Scimed →