Identifiers
- 510(k) Number
- K213771 FDA 510(k)
- FDA Product Code
- DXE 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 Merlin Aspiration System is a catheter designed for embolectomy, specifically for the removal of thromboembolic material from blood vessels. Classified as a Class 2 Cardiovascular device under FDA product code DXE, it is intended for use in procedures where aspiration of clots or debris is required, such as during percutaneous interventions.
This system is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K213771) via the Traditional pathway. It is intended for use in cardiovascular settings, including catheterization labs, and adheres to regulatory standards outlined in 870.5150. The device’s design and performance have been substantiated through risk analysis and testing, ensuring compliance with established safety and effectiveness criteria.
Frequently asked questions
What is the Merlin Aspiration System primarily used for in clinical settings?
The Merlin Aspiration System is designed specifically for embolectomy, meaning it is used to remove thromboembolic material—such as clots or debris—from blood vessels during percutaneous interventions. This makes it ideal for procedures in catheterization labs where clot removal is critical, such as in cardiovascular treatments.
Is the Merlin Aspiration System intended for single-use or reusable applications?
The Merlin Aspiration System is supplied as a reusable medical device. This design allows for multiple uses within a clinical setting, provided proper cleaning, maintenance, and sterilization protocols are followed, ensuring compliance with regulatory standards.
How is the Merlin Aspiration System regulated by the FDA, and what pathway was used for its clearance?
The Merlin Aspiration System is classified as a Class 2 Cardiovascular device under FDA product code DXE and was cleared via the Traditional 510(k) pathway. Its clearance (K213771) was granted on January 27, 2022, after demonstrating substantial equivalence to a predicate device through risk analysis and testing, adhering to FDA standards outlined in 870.5150.
What types of clinical environments is the Merlin Aspiration System intended for?
The system is intended for use in cardiovascular settings, particularly catheterization labs where aspiration of clots or debris is required during percutaneous interventions. Its design and regulatory classification align with procedures involving blood vessels and thromboembolic removal.
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 January 27, 2022 MIVI Neurovascular, Inc. - Food and Drug Administration, Merlin Aspiration System (K213771) — FDA 510 (k) | Innolitics, K213771 FDA 510 (k) - Merlin Aspiration System, Mivi Neurovascular Merlin Aspiration | allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213771 | Class II | Active |
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Manufacturer
- Manufacturer
- Mivi Neurovascular, Inc.
Sources (1)
- FDA 510(k) K213771 24 fields · synced Sep 20, 2026