Open Ended Ureteral Catheter

• 4 recalls, same reason

  • Terminated Z-0736-03 FDA Unclassified (pre-2012) ·initiated 17 Mar 2003
  • Terminated Z-0740-03 FDA Unclassified (pre-2012) ·initiated 17 Mar 2003
  • Terminated Z-0734-03 FDA Unclassified (pre-2012) ·initiated 17 Mar 2003
  • Terminated Z-0735-03 FDA Unclassified (pre-2012) ·initiated 17 Mar 2003

  Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use

510(k) Number

K830840 ↗

FDA Product Code

GBM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Al Askari Percutaneous Access Needle Holder

  Class I

  FDA 510(k) K851162 Active Cleared 15 Apr 1985

• Van-Tec Pediatric Suprapubic Catheter Set

  Class II

  FDA 510(k) K870555 Active Cleared 10 Mar 1987

• Ureteral Catheter Connecting Tube

  Class II

  FDA 510(k) K820866 Active Cleared 26 Apr 1982

• Van-Tec Disposable Flexible Endoscope

  Class II

  FDA 510(k) K860771 Active Cleared 23 Apr 1986

• Van-Tec Segura Stone Basket W/Protective Sheath

  Class II

  FDA 510(k) K870696 Active Cleared 30 Mar 1987

• Van-Tec Bladder Evacuator

  Class II

  FDA 510(k) K880099 Active Cleared 2 Mar 1988

See all devices from Van-Tec, Inc. →