Indigo Aspiration System Aspiration Catheter 6X
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242319 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 Aspiration Catheter 6X is a peripheral mechanical thrombectomy device with aspiration, designed for the removal of thrombi in venous and arterial systems. It operates by mechanically disrupting and aspirating clots to restore blood flow in peripheral vasculature, including treatment of pulmonary embolism.
This catheter is supplied as a single-use device and is intended for use in clinical settings such as catheterization labs or interventional radiology. It is regulated under FDA 510K clearance and the Medical Devices Directive (MDD), with a classification as a Class II device. The device is non-sterile prior to use and must be sterilized by the healthcare provider before application. No specific MRI safety information is provided.
Frequently asked questions
What clinical settings is the Indigo Aspiration System Aspiration Catheter 6X intended for use in?
The Indigo Aspiration System Aspiration Catheter 6X is designed for use in controlled clinical environments such as catheterization labs or interventional radiology suites, where specialized procedures like thrombectomy can be performed safely and effectively.
Is the Indigo Aspiration System Aspiration Catheter 6X single-use or reusable, and how should it be prepared before use?
The device is explicitly labeled as a single-use item. Since it is non-sterile prior to use, it must be sterilized by the healthcare provider before application to ensure proper infection control and safety during the procedure.
What types of blood clots can the Indigo Aspiration System Aspiration Catheter 6X be used to treat?
The catheter is designed for the removal of thrombi (blood clots) in both venous and arterial systems, including peripheral vasculature. This includes applications such as restoring blood flow in cases of pulmonary embolism or other clot-related blockages.
How is the regulatory status of the Indigo Aspiration System Aspiration Catheter 6X defined, and what does this mean for its use?
The device holds FDA 510K clearance and complies with the Medical Devices Directive (MDD), classified as a Class II medical device. This means it has undergone regulatory review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets established safety and performance standards for clinical use.
Are there any special considerations for storage or handling of the Indigo Aspiration System Aspiration Catheter 6X before sterilization?
The device data does not specify storage conditions beyond its non-sterile state prior to use. However, as a single-use item requiring sterilization by the healthcare provider, it should be stored in a clean, dry environment away from direct contamination until ready for preparation. Always follow manufacturer guidelines for sterilization and handling to maintain efficacy and safety.
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 System Catheters Indigo System Indigo System ... - Penumbra, Inc, Indigo R Aspiration System Aspiration Catheter 6X - Penumbra | FDA ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242319 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (2)
- FDA 510(k) K242319 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026