Brawn and Groshong Catheters

• • Terminated Z-1574-2020 FDA Class II ·initiated 1 Oct 2019 ·on shared 510(k) K860256

  Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.

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

510(k) Number

K860256 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Groshong Cv Catheter Repair Kit Open recall

  Class II

  FDA 510(k) K871998 Active Cleared 24 Jun 1987

• Testcorp Preg

  Class II

  FDA 510(k) K831366 Active Cleared 2 Jun 1983

• Cath-Tech Polyurethane Umbilical Vess

  Class II

  FDA 510(k) K842577 Active Cleared 13 Mar 1985

• Umbilical Vessel Catheter

  Class II

  FDA 510(k) K840339 Active Cleared 25 Jul 1984

• Peripherally Inserted Central Venous Catheter

  Class II

  FDA 510(k) K871080 Active Cleared 12 Aug 1987

• Cath-Tech Cholangiography Catheter

  Class II

  FDA 510(k) K842147 Active Cleared 2 Oct 1984

See all devices from Catheter Technology Corp. →