Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System,…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122543 FDA 510(k)
- FDA Product Code
- KRD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3300 FDA 510(k)
- Regulation Number
- 870.3300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Azur Pure Peripheral Coil System is an embolization coil designed for vascular occlusion. It is classified as a vascular device for promoting embolization, consisting of an implantable all-polymer coil housed in an introducer system. The coils are deployed via a stainless steel stylet through a delivery catheter, allowing precise placement within peripheral vessels. Their structure enables targeted occlusion of blood flow, suitable for interventional radiology and vascular surgery procedures.
The system is supplied as a sterile, single-use device intended for use in MRI-compatible settings, as confirmed by non-clinical testing. Available in two pushable sizes (18 and 35), the coils are delivered via standard guidewire techniques within a delivery catheter. The Azur Pure Peripheral Coil System holds FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (KRD product code). Storage and handling follow standard aseptic protocols for implantable devices.
Frequently asked questions
What is the Azur Pure Peripheral Coil System used for?
The Azur Pure Peripheral Coil System is designed for vascular embolization, specifically to occlude blood flow in peripheral vessels. This targeted occlusion is useful in interventional radiology and vascular surgery to treat conditions requiring vessel closure, such as arteriovenous malformations or vascular tumors. The system’s all-polymer coil structure allows for precise deployment via a delivery catheter and stainless steel stylet, ensuring accurate placement within the targeted vessel.
How is the Azur Pure Peripheral Coil System supplied and what are its key features?
The system is supplied as a sterile, single-use device, ensuring safety and compliance with aseptic protocols for implantable devices. It is available in two pushable sizes: 18 and 35. The coils are delivered through a standard guidewire technique within a delivery catheter, making it compatible with common interventional radiology workflows. Additionally, the system is MRI-compatible, as confirmed by non-clinical testing, allowing for post-procedure imaging without interference.
Is the Azur Pure Peripheral Coil System reusable or intended for single-use?
The Azur Pure Peripheral Coil System is explicitly designed for single-use only. This design choice aligns with best practices for implantable medical devices to minimize infection risks and ensure patient safety. Single-use devices also reduce the need for sterilization between procedures, simplifying workflow and maintaining consistency in device performance.
What storage and handling guidelines should be followed for this device?
The Azur Pure Peripheral Coil System must be stored and handled according to standard aseptic protocols for implantable devices. This includes maintaining sterility until use, protecting the device from physical damage, and adhering to manufacturer-recommended storage conditions (e.g., temperature, humidity). Proper storage ensures the device remains effective and safe for its intended clinical application. Always refer to the included instructions for use for specific storage details.
What regulatory pathway does the Azur Pure Peripheral Coil System follow?
The Azur Pure Peripheral Coil System holds FDA 510(k) clearance under the Traditional pathway, classified as a Class II device with the product code KRD. This classification indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meeting established safety and performance standards. The clearance was granted by the FDA’s Cardiovascular (CV) advisory committee, ensuring its compliance with regulatory requirements for vascular embolization devices.
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: Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil ..., PDF DEC 2 0 201 - accessdata.fda.gov, AZUR™ Peripheral Coil System | Terumo Neuro, AZUR™ HydroCoil - terumo-europe.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122543 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K122543 24 fields · synced Oct 1, 2026