Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202821 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 12 and Separator 12 is a Peripheral Mechanical Thrombectomy With Aspiration device, designed for the mechanical removal of fresh, soft emboli and thrombi from peripheral arterial and venous vessels, as well as pulmonary embolisms. This system employs aspiration-based technology to clear occlusions within the vasculature, facilitating revascularization and restoring blood flow.
The device consists of a 12 French Aspiration Catheter and a matching Separator 12, used in conjunction with an aspiration pump, canister, and tubing. It is intended for single-use in clinical settings such as catheterization labs or interventional radiology suites. The system is sterile, supplied as a complete kit, and adheres to FDA 510(k) clearance and MDD (Medical Device Directive) regulatory standards. No MRI safety labeling is specified.
Frequently asked questions
What types of vascular occlusions is the Indigo Aspiration System designed to treat, and where in the body can it be used?
The Indigo Aspiration System is specifically designed for the mechanical removal of fresh, soft emboli and thrombi. It is intended for use in peripheral arterial and venous vessels, as well as pulmonary embolisms, to facilitate revascularization and restore blood flow.
Is the Indigo Aspiration System reusable or intended for single-use, and how is it supplied?
The Indigo Aspiration System is intended for single-use in clinical settings like catheterization labs or interventional radiology suites. It is supplied as a complete kit, including the 12 French Aspiration Catheter, Separator 12, and associated components like tubing and a canister, ensuring readiness for immediate use.
What regulatory pathways has the Indigo Aspiration System followed, and what does this mean for its use in clinical practice?
The Indigo Aspiration System has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD). This means it has undergone evaluation by regulatory authorities to demonstrate safety and effectiveness for its intended use, allowing clinicians to rely on its performance and compliance with established standards.
How is the sterility of the Indigo Aspiration System ensured, and what precautions should be taken during storage?
The Indigo Aspiration System is supplied as a sterile kit, meaning it is pre-sterilized and packaged to maintain sterility until use. Since it is single-use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve sterility and functionality until deployment.
Can the Indigo Aspiration System be used in conjunction with other devices, and what additional equipment is required for its operation?
Yes, the Indigo Aspiration System is designed to work with an external aspiration pump, canister, and tubing. These components are not included in the kit but are necessary to create the suction required for removing emboli and thrombi, enabling effective revascularization during procedures.
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: Penumbra's Newest Generation of Indigo Aspiration System Receives FDA ..., Lightning Indigo System | Peripheral Thrombectomy | Penumbra, Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
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 | K202821 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (2)
- FDA 510(k) K202821 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026