Intraducer Peritoneal Catheter 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8

• • Terminated Z-0428-2007 FDA Unclassified (pre-2012) ·initiated 19 Jan 2007 ·on shared 510(k) K960883

  Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K960883 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• O.P.C. Intravascular Catheter

  Class II

  FDA 510(k) K875082 Active Cleared 8 Mar 1988

• Taut Balloon Catheter, Model 50640

  Class II

  FDA 510(k) K011018 Active Cleared 22 Jun 2001

• Tuat Splatter Control Shield Scs-300

  Class II

  FDA 510(k) K962003 Active Cleared 18 Jul 1996

• Adapt Open Access Port, Model 41233

  Class II

  FDA 510(k) K021731 Active Cleared 8 Aug 2002

• Taut-Insufflation Needle

  Class II

  FDA 510(k) K003703 Active Cleared 22 Feb 2001

• Mini-Port

  Class I

  FDA 510(k) K992904 Active Cleared 5 Oct 1999

See all devices from Taut, Inc. →