Indigo Aspiration System Lightning Flash
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222358 FDA 510(k)
- FDA Product Code
- QEW 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 Indigo Aspiration System Lightning Flash is a Peripheral Mechanical Thrombectomy With Aspiration device, designed to mechanically remove thrombi from peripheral arteries and veins. It employs aspiration tubing to facilitate clot extraction during thrombectomy procedures, aiding in the restoration of blood flow in affected vascular regions.
This system is intended for single-use in interventional radiology and cardiology settings. It is supplied sterile and requires no additional sterilization. The device is classified as Class II under FDA regulations (870.5150) and has received FDA 510K clearance as substantially equivalent to its predicate device. Multiple catheter sizes are available, and proper storage follows manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What types of vascular procedures is the Indigo Aspiration System - Lightning Flash designed to assist with, and where would it typically be used?
The Indigo Aspiration System - Lightning Flash is specifically designed for peripheral mechanical thrombectomy with aspiration, meaning it removes clots (thrombi) from arteries and veins outside the heart and brain. It is intended for use in interventional radiology and cardiology settings, where it helps restore blood flow in affected vascular regions by mechanically extracting clots via aspiration tubing.
Is the Indigo Aspiration System - Lightning Flash intended for single-use or repeated use, and does it require sterilization?
The device is intended for single-use only and is supplied sterile out of the box. Since it is designed for one-time use in procedures, no additional sterilization is required before or after use, as per manufacturer guidelines.
What should I consider when storing the Indigo Aspiration System - Lightning Flash to ensure it remains functional and sterile?
The device must be stored following manufacturer-provided guidelines to maintain sterility and functionality. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, the system is pre-sterilized and packaged for single-use, so proper handling—such as keeping it in its original packaging until use—is critical to preserve its integrity.
Does the Indigo Aspiration System - Lightning Flash come in multiple catheter sizes, and how would I determine which size to use?
Yes, the system offers multiple catheter sizes to accommodate different vascular procedures. The exact sizing options aren’t specified here, but the device is designed to be versatile for peripheral thrombectomy. Selection should be based on clinical assessment and procedural requirements, typically guided by the treating physician’s judgment of the target vessel’s diameter or the clot’s characteristics.
How was the regulatory pathway for the Indigo Aspiration System - Lightning Flash determined, and what does that mean for its use?
The device received FDA 510(k) clearance under the Traditional Review pathway, determined to be substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II medical device (classified under product code QEW for Peripheral Mechanical Thrombectomy With Aspiration). Clinically, this clearance indicates the device has undergone rigorous review to ensure its intended use—mechanical clot removal in peripheral arteries and veins—is supported by scientific evidence.
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: Lightning Flash 2.0 - Penumbra Inc, Lightning Indigo System | Peripheral Thrombectomy | Penumbra, PDF February 2, 2024 Penumbra, Inc. - Food and Drug Administration, INDIGO® Aspiration System - Lightning Flash Aspiration Tubing; INDIGO ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222358 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA 510(k) K222358 24 fields · synced Sep 19, 2026