TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform

K203764•QJP•3/3/2021

Applicant

Imperative Care Inc.

Intended Use

The TracStar Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The ZOOM 88 and ZOOM 88-T Large Distal Platform are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Indications for Use

The TracStar Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The ZOOM 88 and ZOOM 88-T Large Distal Platform are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Predicate Devices

  • K180169 - EagleRay Long Sheath (DQY)
  • K180169 - EagleRay Access Catheter (DQY)