Vascular catheter introduction kit, steerable, single-use

Definition
A collection of sterile, invasive devices intended to provide percutaneous vascular access to enable introduction of a cardiac device/catheter (e.g., cardiac ablation catheter, pacing lead); it is not intended for sub-xiphoid access. It includes a steerable catheter-introducer sheath/dilator assembly intended to be introduced within the cardiac anatomy, a guidewire, and sometimes additional access devices (e.g., introducer needle, haemostatic valve); the catheter is not included. The introducer sheath may include electrodes to assist electrophysiology (EP) monitoring. This is a single-use device.
GUDID devices
4
Last updated
2019-04-02 23:18:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05414734206167Agilis™ST. JUDE MEDICAL, INC.4083122015-11-03
05414734206174Agilis™ST. JUDE MEDICAL, INC.4083132015-11-03
05414734206181Agilis™ST. JUDE MEDICAL, INC.4083142015-11-03
05414734206198Agilis™ST. JUDE MEDICAL, INC.4083152015-11-03