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Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Dev…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K230429

by Rapid Medical Ltd

Identifiers

510(k) Number
K230429 FDA 510(k)
FDA Product Code
NRY 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 Tigertriever Revascularization Device is a Catheter, Thrombus Retriever, designed for mechanical removal of thrombi (blood clots) within coronary arteries. It employs a self-expanding, nitinol-based retrieval system to capture and extract occlusive material, restoring blood flow in acute myocardial infarction or chronic total occlusion scenarios.

The devices are supplied as single-use, non-sterile instruments requiring terminal sterilisation prior to use. Each size (13, 17, or 21 French) is compatible with standard coronary angiography catheters and is intended for use in electrocardiographically monitored procedures. Authorised under FDA 510(k) and MDR, they adhere to Regulation Number 870.1250 and are classified as Class II medical devices. Storage follows manufacturer guidelines for dry, protected conditions until terminal sterilisation.

Frequently asked questions

What are the key differences between the Tigertriever 13, 17, and 21 French sizes, and how do I choose the right one for a procedure?

The Tigertriever devices come in three French sizes—13, 17, and 21—to accommodate varying coronary artery diameters and thrombus sizes. The size selection depends on the patient’s anatomy and the specific occlusion being treated. The 13 French model is typically used for smaller vessels or patients with limited access, while the 17 and 21 French models are designed for larger arteries or more substantial clots, offering greater retrieval capacity. Always consult angiographic imaging and procedural guidelines to match the device size to the patient’s needs.

Are the Tigertriever devices single-use, and if so, what sterilization process is required before use?

Yes, the Tigertriever devices are single-use and supplied in a non-sterile state. Terminal sterilization must be performed prior to use, following the manufacturer’s guidelines. This ensures safety and efficacy before deployment in the catheterization lab.

How should the Tigertriever devices be stored before terminal sterilization, and what conditions should be maintained?

The devices should be stored in dry, protected conditions as per the manufacturer’s instructions until terminal sterilization is performed. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these could compromise the device’s integrity before sterilization.

What regulatory pathways have the Tigertriever devices undergone, and what does this mean for clinicians or purchasers?

The Tigertriever devices have been authorized through both the FDA’s 510(k) pathway and the EU’s Medical Device Regulation (MDR). This means they meet stringent safety and performance standards for mechanical thrombus retrieval in coronary arteries, ensuring compliance with global regulatory requirements for Class II medical devices.

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 (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rapid Medical Ltd
FDA Applicant
Rapid Medical , Ltd.

Sources (2)

  • FDA 510(k) K230429 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026