Indigo Aspiration System – Lightning Aspiration Tubing
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193244 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 Aspiration Tubing is a peripheral mechanical thrombectomy with aspiration device designed to remove clot from arteries and veins in the peripheral vasculature and for the treatment of pulmonary embolism. It facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and Penumbra Aspiration Pump while providing intermittent or continuous aspiration.
Intended users are physicians who have received appropriate training in surgical procedures and/or interventional techniques. The device is supplied as part of the Indigo Aspiration System and is regulated under FDA 510(k) clearance K193244, with product code QEW and regulation number 870.5150. It is manufactured by Penumbra, Inc. in Alameda, CA, and is classified as a Class II medical device.
Frequently asked questions
What is the Indigo Aspiration System Lightning Aspiration Tubing used for?
It is designed to remove clot from arteries and veins in the peripheral vasculature and for the treatment of pulmonary embolism by facilitating vacuum transfer between the INDIGO Aspiration Catheter and Penumbra Aspiration Pump during mechanical thrombectomy procedures.
Who is intended to use the Indigo Aspiration System Lightning Aspiration Tubing?
Physicians who have received appropriate training in surgical procedures and/or interventional techniques are the intended users, as the device requires expertise in vascular access and thrombectomy techniques for safe and effective operation.
How is the Indigo Aspiration System Lightning Aspiration Tubing supplied and regulated?
It is supplied as part of the Indigo Aspiration System and is regulated under FDA 510(k) clearance K193244, with product code QEW and regulation number 870.5150, classified as a Class II medical device manufactured by Penumbra, Inc. in Alameda, CA.
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 Indigo System | Peripheral Thrombectomy | Penumbra, PDF IndIgo lIghtnIng asPIratIon tubIng PreParatIon and use - Penumbra, Inc, Penumbra | Indigo and Lightning - whichmedicaldevice.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193244 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA 510(k) K193244 24 fields · synced Oct 6, 2026