Millipede 070 Aspiration Catheter +1 more model
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250012 FDA 510(k)
- FDA Product Code
- NRY FDA 510(k)
- Models / Variants
- Millipede 070 Aspiration Catheter FDA 510(k)Perfuze Aspiration Tube Set FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Millipede 070 Aspiration Catheter with Perfuze Aspiration Tube Set is a catheter, thrombus retriever designed for mechanical thrombectomy. It is intended for the removal of thrombi within intracranial large vessels, including the internal carotid, middle cerebral (M1 and M2), basilar, and vertebral arteries, to restore blood flow in acute ischemic stroke patients.
This device is supplied as a reusable catheter system paired with a single-use aspiration tube set. It is compatible with aspiration pumps operating at vacuum pressures between -20 inHg and -28 inHg. The system is classified as Class II under FDA regulation 870.1250 and holds a FDA 510K clearance (K250012) for cardiovascular use. Sterility and MRI safety are not specified in the provided data.
Frequently asked questions
What is the primary use of the Millipede 070 Aspiration Catheter with Perfuze Aspiration Tube Set in clinical practice?
The Millipede 070 Aspiration Catheter is specifically designed for mechanical thrombectomy to remove thrombi (blood clots) within intracranial large vessels, such as the internal carotid, middle cerebral (M1 and M2), basilar, and vertebral arteries. Its purpose is to restore blood flow in patients experiencing acute ischemic stroke by clearing these blockages.
Is the Millipede 070 Aspiration Catheter system reusable or single-use, and how does it work with aspiration pumps?
The Millipede 070 Aspiration Catheter system is supplied as a reusable catheter paired with a single-use aspiration tube set. It is compatible with aspiration pumps that operate within a vacuum pressure range of -20 inHg to -28 inHg, enabling effective thrombus removal during mechanical thrombectomy procedures.
What vacuum pressure range should be used when operating the Millipede 070 Aspiration Catheter with an aspiration pump?
The device is designed to function with aspiration pumps that generate vacuum pressures between -20 inHg and -28 inHg. This range ensures optimal performance for thrombus aspiration during intracranial thrombectomy procedures.
How is the Millipede 070 Aspiration Catheter system classified under FDA regulations, and what does this mean for its use?
The Millipede 070 Aspiration Catheter system is classified as Class II under FDA regulation 870.1250 and holds a 510(k) clearance (K250012) for cardiovascular use. This classification indicates it has been deemed substantially equivalent to a legally marketed predicate device, allowing it to be marketed for its intended use in mechanical thrombectomy for acute ischemic stroke.
Are there any specific storage or handling instructions mentioned for the Millipede 070 Aspiration Catheter system?
The provided data does not specify details about storage conditions, handling instructions, or sterility for the Millipede 070 Aspiration Catheter system. Clinicians should refer to the manufacturer’s instructions for use (IFU) for proper storage and preparation, particularly since the aspiration tube set is single-use and the catheter system is reusable.
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: PDF Millipede 070 Aspiration Catheter Instructions for Use - perfuze.com, Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K250012 ..., PDF Millipede 070 Aspiration Catheter Instructions for Use - perfuze.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250012 | Class II | Active |
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Manufacturer
- Manufacturer
- Perfuze, Ltd.
Sources (1)
- FDA 510(k) K250012 24 fields · synced Oct 6, 2026