Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

• • Terminated Z-0863-03 FDA Unclassified (pre-2012) ·initiated 15 Apr 2003

  The label had an expiration date of August 2005, but the correct expiration date was February 2005.

510(k) Number

K023243 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

  Class II

  FDA 510(k) K012347 Active Cleared 23 Aug 2001

• Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

  Class II

  FDA 510(k) K021729 Active Cleared 21 Jun 2002

• Intrastent Ld (Large Diameter) Stent

  Class II

  FDA 510(k) K020528 Active Cleared 16 Apr 2002

• IntraCoil Self-Expanding Peripheral Stent

  Class II

  FDA 510(k) K021563 Active Cleared 31 May 2002

• Protege Self-expanding Nitinol Stent With Starport Delivery Technology

  Class II

  FDA 510(k) K011806 Active Cleared 7 Sep 2001

• Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

  Class II

  FDA 510(k) K012066 Active Cleared 1 Aug 2001

See all devices from Sulzer Intratherapeutics, Inc. →