Codman Bactiseal Barium Striped Catheters

• • Terminated Z-1354-2021 FDA Class II ·initiated 17 Mar 2021

  Incorrect labeling, Catheter did not have the required holes and markings

510(k) Number

K031123 ↗

FDA Product Code

HCA

Device Class

Class II

Regulation

21 CFR Part 882.4100

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Codman Bactiseal EVD Catheter Set

  Class II

  FDA 510(k) K021653 Active Cleared 29 Jul 2002

• Codman* External Drainage System II (Eds-II)

  Class II

  FDA 510(k) K902257 Active Cleared 19 Jul 1990

• Orbit Galaxy G2 Microcoil Delivery System

  Class II

  FDA 510(k) K120686 Active Cleared 4 Apr 2012

• Charnley Femoral Component

  Class II

  FDA 510(k) K760974 Active Cleared 16 Nov 1976

• Vanderbilt Pituitary Retractor

  Class I

  FDA 510(k) K761096 Active Cleared 30 Nov 1976

• Codman Isocool Bipolar Forceps

  Class II

  FDA 510(k) K083895 Active Cleared 23 Jun 2009

See all devices from Codman & Shurtleff, Inc. →