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TracStar LDP Large Distal Platform +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231168

by Imperative Care, Inc.

Identifiers

510(k) Number
K231168 FDA 510(k)
FDA Product Code
QJP FDA 510(k)
Models / Variants
TracStar LDP Large Distal Platform FDA 510(k)
Zoom 88 Large Distal Platform FDA 510(k)
Zoom 88 Large Distal Platform Support FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a catheter, percutaneous, neurovasculature, as defined in the device name and openFDA data. It is a large distal platform designed for use in neurovascular procedures.

It is supplied as a Class II medical device under FDA 510(k) clearance (K231168) and is intended for cardiovascular applications. The device is manufactured by Imperative Care, Inc. and is regulated under regulation number 870.1250.

Frequently asked questions

What is the TracStar LDP Large Distal Platform used for?

The TracStar LDP Large Distal Platform is a percutaneous neurovascular catheter designed for use in neurovascular procedures, as indicated in its device name and openFDA data, and is intended for cardiovascular applications based on its regulatory classification.

How is the TracStar LDP Large Distal Platform supplied and what is its regulatory status?

The device is supplied as a Class II medical device under FDA 510(k) clearance (K231168), meaning it was found substantially equivalent to a predicate device, and is manufactured by Imperative Care, Inc. under regulation number 870.1250.

Is the TracStar LDP Large Distal Platform intended for single-use or reuse?

The device data does not specify whether the TracStar LDP Large Distal Platform is intended for single-use or reuse; therefore, no determination can be made about its reusability based solely on the provided information.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Imperative Care, Inc.

Sources (1)

  • FDA 510(k) K231168 24 fields · synced Oct 6, 2026