Microcatheters
TracStar Large Distal Platform
A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
TracStar Large Distal Platform models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| ICAC088090 | Lumen/Inner Diameter 0.088 in; Outer Diameter 0.108 in; Catheter Length 90 cm | Not stated | Available |
| ICAC088095 | Lumen/Inner Diameter 0.088 in; Outer Diameter 0.108 in; Catheter Length 90 cm | Not stated | Available |
| ICAC088095 | Lumen/Inner Diameter 0.088 in; Outer Diameter 0.110 in; Catheter Length 95 cm | Not stated | Available |
| ICAC088100 | Outer Diameter 0.108 in; Lumen/Inner Diameter 0.088 in; Catheter Length 100 cm | Not stated | Available |
| ICAC088105 | Lumen/Inner Diameter 0.088 in; Outer Diameter 0.108 in; Catheter Length 90 cm | Not stated | Available |
| ICAC088105 | Lumen/Inner Diameter 0.088 in; Outer Diameter 0.110 in; Catheter Length 105 cm | Not stated | Available |
| ICAC088110 | Catheter Length 110 cm; Outer Diameter 0.108 in; Lumen/Inner Diameter 0.088 in | Not stated | Available |
FDA clearances
- 510(k) K212224 September 2021
- 510(k) K180169 August 2018
Procedures that use microcatheters
Frequently asked questions
What is TracStar Large Distal Platform used for?
A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
Who makes TracStar Large Distal Platform?
TracStar Large Distal Platform is made by Imperative Care, Inc.. It is listed under microcatheters in our device library.
What sizes does TracStar Large Distal Platform come in?
Sizes listed for TracStar Large Distal Platform: Lumen/Inner Diameter: 0.09 in; Outer Diameter: 0.11–0.11 in; Catheter Length: 90–110 cm. Confirm availability with the manufacturer's instructions for use.
Is TracStar Large Distal Platform MRI safe?
The FDA device database entry for TracStar Large Distal Platform does not state its MRI safety status. Check the labeling before MRI.
Is TracStar Large Distal Platform FDA cleared?
TracStar Large Distal Platform is covered by FDA submissions K180169, K212224.
How do I contact a Imperative Care, Inc. sales representative?
Imperative Care, Inc. has not listed representatives on LA Vascular yet. Visit the Imperative Care, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.