Indigo Aspiration System Penumbra Engine Pump, Indigo Aspiration System Penumbra Engine Pump Canister
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180105 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 Penumbra Engine Pump and Canister is a Peripheral Mechanical Thrombectomy With Aspiration device, designed for the removal of thrombi and emboli within peripheral vascular systems. This system combines a motorised pump and a canister to facilitate aspiration-based thrombectomy, aiding in the restoration of blood flow in affected arteries.
The device is supplied as a reusable system, intended for use in cardiovascular procedures under sterile conditions. It is classified as a Class II medical device under FDA regulations (870.5150) and has received FDA 510(k) clearance, along with authorisations under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The system is not MRI-safe and must be used in accordance with manufacturer instructions to ensure proper functionality and safety.
Frequently asked questions
What is the primary purpose of the Indigo Aspiration System, and how does it differ from traditional thrombectomy methods?
The Indigo Aspiration System combines a motorized pump and a canister to perform aspiration-based thrombectomy, specifically designed for removing thrombi and emboli within peripheral vascular systems. Unlike some traditional methods that rely solely on mechanical fragmentation or suction alone, this system integrates aspiration with mechanical action to restore blood flow in affected arteries, making it particularly suited for peripheral vascular procedures.
Is the Indigo Aspiration System reusable, and if so, what considerations should be taken into account during use?
Yes, the Indigo Aspiration System is supplied as a reusable system, intended for use in sterile conditions during cardiovascular procedures. Since it is reusable, proper cleaning, sterilization, and maintenance must be followed strictly to ensure functionality and patient safety, as outlined in the manufacturer’s instructions.
Can the Indigo Aspiration System be used in an MRI environment, and what safety precautions should be observed?
No, the Indigo Aspiration System is explicitly not MRI-safe. It must be used in non-MRI environments, and all components should be positioned away from MRI scanners to prevent interference or safety hazards during procedures.
What regulatory pathways has the Indigo Aspiration System undergone, and which agencies have authorized its use?
The Indigo Aspiration System has received FDA 510(k) clearance under the classification of Peripheral Mechanical Thrombectomy With Aspiration (device code QEW), demonstrating substantial equivalence to a predicate device. It is also authorized under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), ensuring compliance with European regulatory standards.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180105 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (2)
- FDA 510(k) K180105 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026