Lysus Infusion System
FDA 510(k)Class II (US FDA 510(k))
by Ekos Corp.
Identifiers
- 510(k) Number
- K060084 FDA 510(k)
- FDA Product Code
- QEY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lysus Infusion System is a Mechanical Thrombolysis Catheter, designed for the controlled and selective infusion of fluids, including thrombolytics, into the peripheral vasculature. It combines a disposable infusion catheter with a removable ultrasound core to facilitate targeted thrombus dissolution within vascular systems.
This system is supplied as a single-use device and is intended for use in cardiovascular settings. It is classified under 21 CFR 870.1210 as a continuous flush catheter and has received FDA 510(k) clearance under Special Review (K060084). The device is not MRI-safe and must be handled and stored according to manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the Lysus Infusion System primarily used for in clinical settings?
The Lysus Infusion System is designed for the controlled and selective infusion of fluids, such as thrombolytics, into the peripheral vasculature to facilitate targeted thrombus dissolution. This makes it particularly useful in cardiovascular procedures where localized treatment of blood clots is required.
Is the Lysus Infusion System intended for reuse, or is it meant to be used only once?
The Lysus Infusion System is explicitly supplied as a single-use device. This means it should not be reused after a single procedure to ensure sterility and functionality, as outlined in the manufacturer’s guidelines.
Can the Lysus Infusion System be used in an MRI environment, or are there specific safety concerns?
The Lysus Infusion System is explicitly stated as not MRI-safe. This means it should not be used in or near an MRI machine, as the device’s materials or components could pose risks during magnetic resonance imaging.
How should the Lysus Infusion System be stored to maintain its integrity?
The device must be handled and stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is single-use, it should remain in its original packaging until immediately before use, and any storage conditions (e.g., temperature, humidity) should align with Ekos Corp.’s recommendations.
What regulatory pathway was followed for the Lysus Infusion System’s approval, and what does that mean for its use?
The Lysus Infusion System received FDA 510(k) clearance under Special Review (K060084), meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance indicates it meets FDA standards for safety and effectiveness as a Mechanical Thrombolysis Catheter, but it does not imply broader approval for all uses—only those specified in its intended purpose.
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. Sources consulted: LYSUS INFUSION SYSTEM (K050472) — FDA 510(k) | Innolitics, EKOS™ Endovascular System - Boston Scientific, Lysus Infusion System (K042456) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060084 | Class II | Active |
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Manufacturer
- Manufacturer
- Ekos Corp.
Sources (1)
- FDA 510(k) K060084 24 fields · synced Sep 19, 2026